Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
National: AZ, CA, CO, CT, DE, FL, GA, IA, IN, KY, NH, NY, OH, OR, PA, TX, WA & WI. International: None reported.
Black Currant Huckleberry, Brioche and Jam Ice Cream Bucket, 313, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Black Currant Huckleberry, Brioche and Jam Pint Case, 215, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Black Currant Huckleberry, Brioche and Jam pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
All lots distributed were between July 1, 2013 and April 22, 2015.
Approximately 61,267 total units for all 3 gallon sized products (buckets). Approximately 1,513,227 total units for all pint sized products.
Product may be contaminated with Listeria monocytogenes.
Black Walnut Divinity Ice Cream Bucket, 373, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Walnut Divinity Pint Case, 273, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Black Walnut Divinity Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Blue Ice Cream Bucket, 807, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Blue Ice Cream Pint Case, 707, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Blue Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Milk Chocolate Bombay N.3 Ice Cream Bucket, 364, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Bombay, Milk Chocolate Ice Cream Pint Case, 264, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Bombay, Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Brambleberry Crisp Ice Cream Bucket, 307, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Brambleberry Crisp Ice Cream Pint Case, 290, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Brambleberry Crisp Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Brown Ice Cream Bucket, 803, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Brown Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.    Brown Ice Cream Pint Case, 703, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.
Brown Butter Almond Brittle Ice Cream Bucket, 308, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Brown Butter Almond Brittle Ice Cream Pint Case, 253, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Brown Butter Almond Brittle Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttercup Pumpkin w/Amaretti Cookies Ice Cream Bucket, 304, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Buttercup Pumpkin w/Amaretti Cookies Ice Cream Pint Case, 204, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Buttercup Pumpkin w/Amaretti Cookies Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cedarwood Vanilla Ice Cream Bucket, 398, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cedarwood Vanilla Ice Cream Pint Case, 298, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Cedarwood Vanilla Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cherries Kickapoo Ice Cream Bucket, 356, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cherries Kickapoo Ice Cream Pint Case, 256, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Cherries Kickapoo Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cherry Lambic Ice Cream Bucket, 328, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cherry Lambic Ice Cream Pint Case, 228, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Cherry Lambic Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Chocomole Ice Cream Bucket, 399, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Chocomole Ice Cream Pint Case, 299, Jenis' Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Chocomole Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cinderella Pumpkin Ice Cream Bucket , 371, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cinderella Pumpkin Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Cinderella Pumpkin Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Cinderella Pumpkin Ice Cream Pint Case, 271, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets). Approximately 15,045 total units for all half gallon sized products. Appro
Cloverton Ice Cream Bucket, 351, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cloverton Ice Cream Pint Case, 251, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Cloverton Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Dark Chocolate Ice Cream Bucket, 311, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Dark Chocolate Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.    Dark Chocolate Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.    Dark Chocolate Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Dark Chocolate Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Dark Chocolate Ice Cream Pint Case, 201, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Dark Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets); 57,719 for all 6oz sized prods (Indies) & 1,513,227 for all pint sized pro
Double-Toasted Coconut Ice Cream Bucket, 349, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Double-Toasted Coconut Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Double-Toasted Coconut Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Eclair Ice Cream Bucket, 810, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Eclair Ice Cream Pint Case, 710, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Eclair Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Goat Cheese w/Red Cherries Ice Cream Bucket, 312, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Goat Cheese w/Red Cherries Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Goat Cheese w/Red Cherries Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Goat Cheese w/Red Cherries Ice Cream Pint Case, 216, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Goat Cheese w/Red Cherries Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets); 15,045 for all half gallon sized prds; 1,513,227 for all pint sized prods.
Gooey Buttercake Ice Cream Bucket, 820, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Gooey Buttercake Ice Cream Pint Case, 720, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Gooey Buttercake Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Green Ice Cream Bucket, 805, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Green Ice Cream Pint Case, 705, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Green Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Intelligentsia Black Cat Espresso Ice Cream Bucket, 347, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Intelligentsia Black Cat Espresso Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.    Intelligentsia Black Cat Espresso Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.    Intelligentsia Black Cat Espresso Ice Cream Pint Case, 247, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Intelligentsia Black Cat Espresso Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets); 57,719 for all 6oz sized prds (Indies); 1,513,227 for all pint sized prods
Key Lime Bucket, 337, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Key Lime Pint Case, 237, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Key Lime Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Loveless Biscuits + Peach Jam Ice Cream Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Loveless Biscuits + Peach Jam Ice Cream Pint Case, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Loveless Biscuits + Peach Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Middle West Whiskey Eggnog Ice Cream Bucket, 372, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Middle West Whiskey Eggnog Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Middle West Whiskey Eggnog Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Middle West Whiskey Eggnog Ice Cream Pint Case, 272, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Middle West Whiskey Eggnog Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Moonshine Corn Syrup Custard & Pecans Bucket, 361, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Moonshine Corn Syrup Custard & Pecans Pint Case, 261, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Moonshine Corn Syrup Custard & Pecans Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Ndali Estate Vanilla Bean Ice Cream Bucket, 326, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Ndali Estate Vanilla Bean Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.    Ndali Estate Vanilla Bean Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.    Ndali Estate Vanilla Bean Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Ndali Estate Vanilla Bean Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Ndali Estate Vanilla Bean Ice Cream Pint Case, 240, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Ndali Estate Vanilla Bean Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 (1), 57,719 (2), 1,513,227 (3) total units for all 3 gallon buckets (1), 6oz Indies (2), pint (3) sized products.
Orange Bucket, 806, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Orange Pint Case, 706, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Orange Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Oregon Fir Ice Cream Bucket, 363, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Oregon Fir Ice Cream Pint Case, 263, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Oregon Fir Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Dark Chocolate Peppermint Ice Cream Bucket, 331, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Dark Chocolate Peppermint Ice Cream Pint Case, 231, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Dark Chocolate Peppermint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Pfeffernusse Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets).
Pistachio & Honey Ice Cream Bucket, 319, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Pistachio & Honey Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.    Pistachio & Honey Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.    Pistachio & Honey Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Pistachio & Honey Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Pistachio & Honey Ice Cream Pint Case, 209, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Pistachio & Honey Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 (1), 57,719 (2), 1,513,227(3) total units for all 3 gallon buckets (1), 6oz Indies (2), pint (3) sized products.
Pumpernickel Ice Cream Bucket, 376, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Pumpernickel Ice Cream Pint Case, 276, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Pumpernickel Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Queen City Cayenne Ice Cream Bucket, 320, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Queen City Cayenne Ice Cream Pint Case, 211, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Queen City Cayenne Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Raspberry Red Currant, Brioche and Jam Bucket, 316, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Raspberry Red Currant, Brioche and Jam Pint Case, 223, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Raspberry Red Currant, Brioche and Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Red Currant Cloverton Bucket, 377, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Red Currant Cloverton Pint Case, 277, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Red Currant Cloverton Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Riesling Poached Pear Sorbet Bucket, 321, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Riesling Poached Pear Sorbet Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.    Riesling Poached Pear Sorbet Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.    Riesling Poached Pear Sorbet Pint Case, 210, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Riesling Poached Pear Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Roasted Strawberry Buttermilk Ice Cream Bucket, 323, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Roasted Strawberry ButtermilkIce Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  Roasted Strawberry Buttermilk Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.  Roasted Strawberry Buttermilk Ice Cream Pint Case, 218, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Roasted Strawberry Buttermilk Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Roxbury Road Ice Cream Bucket, 362, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Roxbury Road Ice Cream Pint Case, 262, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Roxbury Road Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Rum Ball Ice Cream Bucket, 384, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Rum Ball Ice Cream Pint Case, 284, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Rum Ball Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Saison Flax Bucket, 357, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Saison Flax Pint Case, 257, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Saison Flax Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 1,513,227 total units for all pint sized products.
Salty Caramel Ice Cream Bucket, 301, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Salty Caramel IIce Cream ndie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  Salty Caramel Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.  Salty Caramel Ice Cream Half Gallon Case, 400, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.  Salty Caramel Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.  Salty Caramel Ice Cream Pint Case, 200, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Salty Caramel Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Salty Vanilla Custard Bucket, 336, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Salty Vanilla Custard Pint Case, 236, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Salty Vanilla Custard Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Savannah Buttermint Ice Cream Bucket, 388, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Savannah Buttermint Ice Cream Half Gallon Case, 411, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.  Savannah Buttermint Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.  Savannah Buttermint Ice Cream Pint Case, 288, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Savannah Buttermint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Seven Layer Bar Ice Cream Bucket, 393, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Seven Layer Bar Ice Cream Pint Case, 293, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Seven Layer Bar Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Smoked Chocolate Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Spiced Purple Yam Bucket, 329, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Spiced Purple Yam Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  Spiced Purple Yam Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets). Approximately 57,719 total units for all 6oz sized products. (Indies)
Stauf's Black Coffee Bucket, 355, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Stauf's Black Coffee Pint Case, 203, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Stauf's Black Coffee Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Sun-Popped Corn Bucket, 815, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sun-Popped Corn Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Sweet Corn & Black Raspberries Ice Cream Bucket, 324, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Corn & Black Raspberries Ice Cream Pint Case, 219, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Sweet Corn & Black Raspberries Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Sweet Cream Biscuits w/ Jam Ice Cream Bucket, 359, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Cream Biscuits w/ Jam Ice Cream Pint Case, 259, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Sweet Cream Biscuits w/ Jam Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Sweet Cream w/ Molasses & Peanuts Ice Cream Bucket, 352, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Cream w/ Molasses & Peanuts Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.  Sweet Cream w/ Molasses & Peanuts Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.  Sweet Cream w/ Molasses & Peanuts Ice Cream Pint Case, 252, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Sweet Cream w/ Molasses & Peanuts Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets). Approximately 61,267 total units for all 3 gallon sized products (buckets)
Sweet Potato w/Torched Marshmallows Ice Cream Bucket, 333, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Sweet Potato w/Torched Marshmallows Ice Cream Pint Case, 233, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Sweet Potato w/Torched Marshmallows Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
The Buckeye State Ice Cream Bucket, 309, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Buckeye State Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  The Buckeye State Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.  The Buckeye State Ice Cream Pint Case, 265, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  The Buckeye State Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
The Milkiest Chocolate in the World Ice Cream Bucket, 325, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. The Milkiest Chocolate in the World Ice Cream Pint Case, 294, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  The Milkiest Chocolate in the World Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Torrone Ice Cream Bucket, 378, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Torrone Ice Cream Pint Case, 278, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Torrone Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Triumph Ice Cream Bucket, 381, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Triumph Ice Cream Pint Case, 281, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Triumph Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Whiskey & Pecans Ice Cream Bucket, 335, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Whiskey & Pecans Ice Cream Pint Case, 234, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Whiskey & Pecans Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
White Chocolate Coconut Bucket, 819, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Coconut Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
White Chocolate Peppermint Ice Cream Bucket, 375, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. White Chocolate Peppermint Pint Case, 275, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  White Chocolate Peppermint Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Wildberry Lavender Ice Cream Bucket, 327, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wildberry Lavender Ice Cream Pint Case, 220, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Wildberry Lavender Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Wintermint Bucket, 310, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Yazoo Sue w/Rosemary Bar Nuts Ice Cream Bucket, 392, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Yazoo Sue w/Rosemary Bar Nuts Ice Cream Pint Case, 292, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Yazoo Sue w/Rosemary Bar Nuts Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Yellow Bucket, 813, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Yellow Pint Case, 713, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Yellow Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Apricot, Brioche and Jam Bucket, 300, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Apricot, Brioche and Jam Pint Case, 207, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Apricot, Brioche and Jam Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Askinosie Dark Milk Chocolate Ice Cream Bucket, 353, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Askinosie Dark Milk Chocolate Ice Cream Pint Case, 213, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Askinosie Dark Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Backyard Mint Ice Cream Bucket, 302, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Backyard Mint Ice Cream Pint Case, 214, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Backyard Mint Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Banana French Toast Bucket, 354, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Banana French Toast Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.  Banana French Toast Pint Case, 254, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Banana French Toast Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Banana Pudding Bucket, 811, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Banana Pudding Pint Case, 711, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Banana Pudding Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Bananas & Honey Ice Cream Bucket, 374, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Bangkok Peanut Ice Cream Bucket, 303, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bangkok Peanut Ice Cream Pint Case, 212, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Bangkok Peanut Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Batdorf Black Coffee Bucket, 366, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Batdorf Black Coffee Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  Batdorf Black Coffee Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.  Batdorf Black Coffee Pint Case, 266, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Batdorf Black Coffee Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Batdorf Coffee w/ Cream & Sugar Bucket, 383, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Batdorf Coffee w/ Cream & Sugar Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Birch + Marshmallows Ice Cream Bucket, 379, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Birch + Marshmallows Pint Case, 279, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Birch + Marshmallows Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Black Bucket, 812, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Pint Case, 712, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Black Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Bergamot Frozen Yogurt Bucket, 348, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Bergamot Frozen Yogurt Pint Case, 248, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Bergamot Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Black Currant Frozen Yogurt Bucket, 305, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Currant Frozen Yogurt Pint Case, 217, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Black Currant Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttermilk, Grapefruit Frozen Yogurt Bucket, 338, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Grapefruit Frozen Yogurt Pint Case, 225, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Grapefruit Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttermilk, Lemon & Blueberry Frozen Yogurt Bucket, 814, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lemon & Blueberry Frozen Yogurt Pint Case, 714, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Lemon & Blueberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Lemon ButtermilkFrozen Yogurt Bucket, 809, Jenis Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lemon Frozen Yogurt Indie Case, 103, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.  Buttermilk, Lemon Frozen Yogurt Indie, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.  Buttermilk, Lemon Frozen Yogurt Pint Case, 709, Jenis Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Lemon Frozen Yogurt Pint, Jenis Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttermilk, Lime Cardamom Frozen Yogurt Bucket, 306, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Lime Cardamom Frozen Yogurt Pint Case, 206, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Lime Cardamom Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttermilk, Mango Lassi Frozen Yogurt Bucket, 341, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Mango Lassi Frozen Yogurt Pint Case, 235, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Mango Lassi Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Buttermilk, Passion Fruit Frozen Yogurt Bucket, 340, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Buttermilk, Red Raspberry Frozen Yogurt Bucket, 339, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Buttermilk, Red Raspberry Frozen Yogurt Pint Case, 226, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Buttermilk, Red Raspberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cranberry Parfait Buttermilk Frozen Yogurt Bucket, 382, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Cranberry Parfait Buttermilk Frozen Yogurt Pint Case, 282, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Cranberry Parfait Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Green Tomato Buttermilk Frozen Yogurt Buckets, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Guava Buttermilk Frozen Yogurt Bucket, 342, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.
Huckleberry Frozen Yogurt Bucket, 343, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Huckleberry Frozen Yogurt Pint Case, 243, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Huckleberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Lemon & Blueberries Frozen Yogurt Bucket, 314, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Lemon & Blueberries Frozen Yogurt Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.  Lemon & Blueberries Frozen Yogurt Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.  Lemon & Blueberries Frozen Yogurt Pint Case, 267, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Lemon & Blueberries Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Lemon Frozen Yogurt Bucket, 315, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Lemon Frozen Yogurt Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen.    Lemon Frozen Yogurt Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.    Lemon Frozen Yogurt Pint Case, 208, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Lemon Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 61,267 total units for all 3 gallon sized products (buckets); 57,719 for all 6oz sized prods (Indies); 1,513,227 for all pint sized prod
Mango Lassi Frozen Yogurt Bucket, 391, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Mango Lassi Frozen Yogurt Pint Case, 297, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Mango Lassi Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Pineapple Cake Frozen Yogurt Bucket, 358, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Pineapple Cake Frozen Yogurt Pint Case, 258, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Pineapple Cake Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Rainbow Frozen Yogurt Bucket, 344, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Rainbow Frozen Yogurt Pint Case, 244, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Rainbow Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Red Raspberry Frozen Yogurt Bucket, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Red Raspberry Frozen Yogurt Poppin' J Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 25 containers per case, frozen.    Red Raspberry Frozen Yogurt Pint Case, 241, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Red Raspberry Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Tart, Lemon Buttermilk Frozen Yogurt Bucket, 380, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Tart, Lemon Buttermilk Frozen Yogurt Pint Case, 280, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Tart, Lemon Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice   Creams, LLC, pint size, plastic container, individually packed, frozen.
Watermelon Buttermilk Frozen Yogurt Bucket, 817, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Watermelon Buttermilk Frozen Yogurt Pint Case, 717, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.  Watermelon Buttermilk Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Black Currant Lambic Sorbet Bucket, 385, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Black Currant Lambic Sorbet Pint Case, 285, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Black Currant Lambic Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Blood Orange Sorbet Bucket, 387, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Blood Orange Sorbet Pint Case, 287, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Blood Orange Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Cantaloupe & Sun Tea Sorbet Bucket, 360, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Cantaloupe & Sun Tea Sorbet Pint Case, 260, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.    Cantaloupe & Sun Tea Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Wheatgrass, Pear, & Vinho Verde Sorbet Bucket, 808, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Wheatgrass, Pear, & Vinho Verde Sorbet Pint Case, 708, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.
Bitter Lemon Ice Bucket, 816, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Bitter Lemon Ice Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Blue Raspberry Ice Bucket, 818, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen.   Blue Raspberry Ice Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Guava Buttermilk Frozen Yogurt Sandwich Case, 507, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen.
Approximately 236,267 total units for all regular sized (5oz to 6.2oz) sandwich products.
Orchid Vanilla Macaroon Ice Cream Sandwich Case, 503, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, 14 boxes per case, frozen.   Mini Orchid Vanilla Macaroon Ice Cream Sandwich Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen.
Approximately 236,267 total units for all regular sized (5oz to 6.2oz) sandwich products. Approximately 16,814 total units for all mini sandwich produ
Orchid Vanilla Macaroon Sandwich, Jeni's Splendid Ice Creams, LLC, 5oz sandwich, paper box, individually packed, frozen.
Dark Chocolate Hazelnut Macaroon Sandwich Case, 502, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, 14 boxes per case, frozen.   Dark Chocolate Hazelnut Macaroon Sandwich, Jeni's Splendid Ice Creams, LLC, 6.2oz sandwich, paper box, individually packed, frozen.    Mini Dark Chocolate Hazelnut Macaroon Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen.
Pfeffernusse Macaroon Sandwich Case - for scoop shop orders, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen.
Pfeffernusse Sandwich - NOT FOR SCOOP SHOP ORDERS, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen.
Salty Caramel Macaroon Case, 504, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen.   Salty Caramel Macaroon Sandwich, Jenis Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen.     Mini Salty Caramel Macaroon Case, Jenis Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen.
Approximately 236,267 total units for all regular sized (5oz to 6.2oz) sandwich products.  Approximately 16,814 total units for all mini sandwich prod
Smoked Dark Chocolate Macaroon Ice Cream Sandwich Case, Jeni's Splendid Ice Creams, LLC, 6-oz sandwich, paper box, 14 boxes per case, frozen.
Snowy Coconut Macaroon Ice Cream Sandwich Case, 515, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen.   Snowy Coconut Macaroon Ice Cream Sandwich, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, individually packed, frozen.
Rum Ball Split Case, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Rum Ball Split, Jenis Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen.
Approximately 57,719 total units for all 6oz sized products. (Indies)
Wintermint Sandwich Case, 506, Jeni's Splendid Ice Creams, LLC, 6oz sandwich, paper box, 14 boxes per case, frozen.
Ohio Maple Brittle Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.
Approximately 15,045 total units for all half gallon sized products.
Sweet Cream Ice Cream Half Gallon Case, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, 4 half gallons per case, frozen.   Sweet Cream Ice Cream Half Gallon, Jeni's Splendid Ice Creams, LLC, half gallon, plastic container, individually packed, frozen.     Sweet Cream Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Approximately 15,045 total units for all half gallon sized products. Approximately 1,513,227 total units for all pint sized products.
Mini Chocolate Truffle Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen.
Approximately 16,814 total units for all mini sandwich products.
Mini Dark Chocolate Hazelnut Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, individually packed, frozen.   Mini Dark Chocolate Hazelnut Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen.
Mini Lemon-Orchid Sandwich Case, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen.   Mini Lemon-Orchid Sandwich Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, plastic bag, 7 sandwiches per sleeve, frozen.
Mini Orchid Vanilla Macaroon Case, Jenis Splendid Ice Creams, LLC, mini Sandwich, paper box, 8 sleeves per case, frozen, 7 sandwiches per sleeve, frozen.
Mini Salty Caramel Sandwich, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, individually packed, frozen.   Mini Salty Caramel Sleeve, Jeni's Splendid Ice Creams, LLC, mini Sandwich, paper box, 7 sandwiches per sleeve, frozen.
Askinosie Dark Milk Chocolate Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Beet + Grapefruit Shrub Sorbet Pint Case, 205, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Beet + Grapefruit Shrub Ssorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Eggnog Special Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Feuerzangenbowle Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Hot Toddy Sorbet Pint Case, 202, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Hot Toddy Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Smoked Cassia Cinnamon Ice Cream Pint Case, 224, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Smoked Cassia Cinnamon Ice Cream Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
White House Blueberry Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Apricot Frozen Yogurt Pint Case, 238, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Apricot Frozen Yogurt Pint, Jenis Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Grapefruit Frozen Yogurt Pint Case, 296, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Grapefruit Frozen Yogurt Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Passion Fruit Sorbet Pint Case, 289, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Passion Fruit Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.    Passion Fruit Sorbet Pint Case, 289, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.
Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen. Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Red Raspberry Sorbet Pint Case, 286, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen.   Red Raspberry Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Sugar Plum Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
White Grapefruit Sorbet Pint, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, individually packed, frozen.
Blackout Terrine Slice, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, individually packed, frozen.   Blackout Terrine Slice Case, Jeni's Splendid Ice Creams, LLC, Slice, plastic bag, 12 slices per case, frozen.
Red Blood Cells Leukocytes Reduced, Irradiated
1 unit, subsequently divided into 4 pediatric aliquots
Irradiated Red Blood Cells, not manufactured according to specifications, were distributed.
Worldwide Distribution: US (Nationwide) and country of: Switzerland.
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US).  Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
OmniPod Insulin Management System. Only the OmniPod device is affected.  Catalog Number(s): 14810 (OUS).  Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Product distributed in Oregon and California
CocoNoNut CACAO-NECTAR BAR, Honey Mama's brand, Net wt. 2.5 oz. (70.8 g), UPC 8 54835 00406 7   Square in size, 3''X3'' with a bright orange label around a butcher paper wrapper.    12 bars/case
1 distributor located in Oregon, and 2 direct consignees - one located in Oregon and the other in Half Moon Bay, CA
CocoNoNut CACAO-NECTAR BAR because it may contain undeclared almond.
Worldwide Distribution - US (nationwide) and to the countries of : Afghanistan, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia Herzegovinia, Bulgaria, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Ghana, Great Britain, Greece, Guatemala, Hungary, Iraq, Ireland, Honduras, Hong Kong, Iceland, Indonesia, India, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Libya, Macedonia, Malaysia, Mali, Mexico, Myanmar, Morocco, Netherlands, Nepal, Nicaragua, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkmenistan, United Arab Emirates,  Uruguay, Venezuela, Vietnam and Yemen.
Dimension CREA (Creatinine) and  Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.
Total number Dimension Vista - 32,165,  Dimension - 238,634
Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, which did not meet the criteria for leukoreduced products, were distributed.
Walter L. Shepeard Community Blood Center, Inc.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Penrose-St Francis Health Services Blood Bank
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which did not meet acceptable product specifications, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who had been incarcerated, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, in which quality control and distribution/failure to quarantine unit due to medical history, were distributed.
Blood product, which quality control and distribution of product  did not meet specifications, was distributed.
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
Chemical Contamination; benzophenone leached from the product label varnish
Felodipine Extended-Release Tablets,  5 mg, 100 count bottles,  Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Nationwide, Puerto Rico, and to foreign distribution centers in Dominican Repulbic, Malaysia, Mexico, Panama, Peru, and United Arab Emirates.
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0 03 17518 01108 5) and b) 0.2 fl oz, 6 mL Single Use Applicator w/urethane sponge per pouch, packaged in 50 pouches per case (NDC 17518-0011-07, UPC (01) 0 03 17518 01107 8), OTC, Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144.
a) 4460 cases (0.9 fl oz, 26 mL Single Use Applicator, 20 pouches per case), b) 1059 cases (2 fl oz, 6 mL Single Use Applicator, 50 pouches per case)
Chemical contamination: Product may be contaminated with a toxic compound.
Worldwide Distribution-US (nationwide) including the states of  CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Blood products, collected from a donor who was taking the medication Proscar, were distributed.
Blood products, which may have been exposed to unacceptable temperatures during shipment, were distributed.
Blood products, collected using a mixer/scale device which failed quality control testing, were distributed.
Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch.   The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90 driver in order to retain and drive the screw into the occipital bone.
Biomet has initiated a recall on  Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration.  Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Platelets Pheresis Leukocytes Reduced Irradiated Washed
Blood product, in which component not prepared in accordance with specifications, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed.
Blood product, in which quality control and distribution of product  did not meet specifications, was distributed.
Blood product, for which the quality control testing was incomplete, was distributed.
METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.
Presence of Foreign Substance: Presence of hair.
Mindray DS USA, Inc. dba Mindray North America
Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)   Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
Mindray has identified an issue where the DPM 7 Monitor may display a black screen.
NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE.  For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively.  Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.
Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500;   software version 1.69.
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
Nationwide Distribution including Distributed  nationwide to OH, LA, TX, and GA.
Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System.  Lot 375440.
Model Number 14-521614B, lot number 375440.
Domestic: MI, IN, IL, WI, MO, NE, OH   Foreign: Canada  DOD/VA: None
IQF Red Tart Cherries,  30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case.
Potential for adulteration - elevated mold, yeast, and coliform counts
Red Tart Pitted Cherries, 5 Parts Fruit and 1 Part Sugar,  30 lbs. bulk pails, 15 lbs, in bulk pails
Red Tart Pitted Cherries, Straight Packed (No Sugar),  5 lbs. bulk pails, 30 lbs, in bulk pails
My Fair Baby brand Baby Wipes, Blue package, Item No. 10485-24, 80 Baby Wipes, 24 packages per case
The imported baby wipes were found to be contaminated with bacteria based on FDA sampling and analysis.
My Fair Baby brand Baby Wipes, Pink package, Item No. 10486-24, 80 Baby Wipes per package, 24 packages per case
Red Blood Cells Leukocytes Reduced Irradiated
Worldwide Distribution - US Nationwide and countries of:  Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM).   Product Usage:  Hip joint prosthesis
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers:  74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM)   Product Usage:  Hip joint prosthesis
Worldwide Distribution-US (nationwide) including the states of  AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.
Medivators has recalled a subset of their Hemocor High Performance Hemoconcentrators, due to low ultrafiltration performance that is below product specification.   Medivators includes a single lot (759491A) of model HPH-700 in this recall. Based on additional information provided by the manufacturer, Medtronic has made the precautionary decision to also include specific lots of models HPH-400TS and HPH-1000TS and a 2nd lot of model HPH-700. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11,  TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3,   TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A,  BB7M38Rll,   M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B.  Enables the perfusionist to manage the patient's hematocrit and fluid status.
Worldwide Distribution - US (nationwide) and Internationally to  Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14;    The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Intuitive Surgical has found that in certain circumstances involving select da Vinci Si Single-Site instruments,  the jaws of grip actuated instruments may become fixed in a closed position.
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13.     The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC: 0064-1080-11
Chemical contamination; Naphthalene compound identified in the product after complaints of a petroleum odor
CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
US distribution:  Nationwide Foreign Distribution to the following; Canada, Saudi Arabia, UK, France, Germany, Greece, Italy, South Africa, Kuwait, Romania, Slovenia, Macedonia, Netherlands, Russia, Sweden, Finland, Spain, Turkey, UAE, Brazil, China, Chile, Costa Rica, Japan, Malaysia, Puerto Rico, Taiwan, Vietnam
LABType  LABType HD Class II DRB1 Typing Test  Catalog ID: RSSOH2B1  Lot Number: 009  One Lambda- A Thermo Fisher Scientific Brand  21001 Kittridge Street, Canoga Park, CA 91303 USA
Catalog ID: RSSOH2B1 Lot Number: 009  Batches: 1-36  Article Number: RSSO-LTYP-PI, Rev 24
Misbranded HLA Typing Assay was distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05