US Nationwide distribution in the state of IL
Medpro Elastomeric Infusion Pump.   AccuFlux, Model # CT-0020-100H.       Product Usage:  The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
Please be aware that this is not a new recall. The firm has taken action; but, due toadministrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of 15%.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Products were distributed nationwide and internationally to Australia, Bahamas, Bermuda, Canada, Croatia, Curacao, New Zealand, Trinidad and Tobago, U.S. Virgin Islands, Jamaica, and United Kingdom.
X-ROCK  For Men, Dietary Supplement, Directions: Take one capsule 1-2 hours prior to intimacy.  Made In The USA, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312,  0 00309 50792 7.                             UPC on labeling is:  0 00309 50792 7.    UPC in Press Release is:  0030950792.
Marketed Without an Approved NDA/ANDA: Product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Nationwide to retailers (80%) and consumers (direct and sample 20 %) - approximate
Product is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label.  The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz.  The product label reads in part:  ''Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber Prebiotics Aloe Vera Promotes Gentle Regularity Supports Health Bacteria Balances Stomach Acidity***Isomaltooligosaccharides (Prebiotic Fiber),***Galactooligosaccharides***Other Ingredients:  Purified Water***Manufactured By: Botanical Laboratories, Inc. Ferndale, WA 98248 USA***''
Original Recalled Codes: 16 oz: LOT 34441C XXXXA EXP 03/2014 and 33.8 oz: LOT 34552C XXXXA EXP 03/2014   Expanded Recalled Codes: 33923A XXXXA EXP 12/2012, 33973A XXXXA EXP 12/2012,  34011A XXXXA EXP 10/2012,  34068A XXXXA EXP 12/2012, 34148A XXXXA EXP 12/2012, 34190B XXXXA EXP 01/2013, 34309B XXXXA EXP 03/2013, 34310B XXXXA EXP 03/2013, 34346B XXXXA EXP 03/2013, 34400B XXXXA EXP 08/2013 and  34406B XXXXA EXP 08/2013    The first five digits are uniquely generated by an inventory management program - Macola - followed by a letter representing the year.  XXXX signifies a four digit variable time code stamp, followed by a letter designating the compound vessel used.  Below is the expiration month and year.
2 oz.- 6,509,16oz - 10,846 and 33.8oz - 21,093 units (minus some quality and production retains)
Product (''Digestive 3 in 1 Health'') was manufactured using a raw ingredient that tested positive for Salmonella by the raw ingredient supplier.
US Nationwide Distribution in the states of:  CO, IL, IN, KS, LA, MA, MN, MO, NE,  OH, OK, TN, TX, VA, and WI.
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case.     Product Usage:  The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
The tip of the product could come loose or unravel.
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
Presence of Particulate Matter:  visible crystalline particulates and the discovery of crystalline particulate in a retain sample
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Community Blood Centers of South Florida, Inc.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product was distributed to three distributors/wholesalers and then distributed nationwide by internet and retail sales.
X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by:  MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL,  Also, labeled as X-Rock 3 Day Pill For Erectile Refunction, Distributed by www. CoralXRock.Com, Florida Keys, Florida
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Z-ROCK All Natural Male Supplement. 1 capsule blister pack, UPC 0 00309 50792 7, Distributed by Zrock USA PO Box 668297, Pompano Beach, FL 33066
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
Blood products, collected from a donor whose initial physical exam was not performed within a week of donating, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor who lived with a hepatitis B positive individual, were distributed.
Community Blood Bank of Lancaster County Medical Society
Blood product, collected from a donor with a history of Hepatitis A, was distributed.
American National Red Cross, Penn Jersey Region
Blood product, positive for the S antigen but labeled S negative, was distributed.
Northern California Community Blood Bank
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products collected from a therapeutic donor with polycythemia, were distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with platelet count below the specified minimum requirement, was distributed.
Blood product, collected from a donor who reported travel through a malarial endemic area, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria for a divided unit, were distributed.
Blood products, collected from a donor who had previously been deferred, were distributed.
Blood products, collected from a donor's arm that was documented as unacceptable, were distributed.
Blood products, collected from a therapeutic donor and not labeled to indicate the type of donation, were distributed.
Blood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood Systems, Inc. dba United Blood Services
Community Blood Centers of Florida, Inc.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Puerto Rico only (hotels, gas stations, restaurants)
''***Productos El Gauchito Empanadillas Argentinas Caprese (Caprese Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***''
Undeclared milk as the source of cheese. Undeclared wheat, soy and FD&C Yellow #5, Yellow #6 and Red #40 contained in soft dough shells.
''***Productos El Gauchito Empanadillas Argentinas de Guayaba y Queso (Guava and Cheese Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***''
''***Productos El Gauchito Empanadillas Argentinas de Espinaca (Spinach Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***''
Undeclared soy and FD&C Yellow #5, Yellow #6 and Red #40 contained in soft dough shells.
''***Productos El Gauchito Empanadillas Argentinas de Queso y Cebolla (Cheese and OnionTurnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***''
Undeclared soy, FD&C Yellow #6 and Red #40 contained in soft dough shells.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000     Product Usage:  The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
All sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895.     QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U.    HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050.    HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050.    Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX.    Note: an X was used to represent variations of catalogue numbers.
It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator.  This event has occurred in about 0.01% (1:10,000) of units shipped.
Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
''***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***''   To create pathway for insertion of CrossFT Suture Anchor into bone.
Lot # 330889 and Catalog: PFT-00M - No Expiration date
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled.  The correct handle is a clear anodized silver colored handle.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the countries of ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BULGARIA, CANADA CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GREAT BRITAIN, GEORGIA, GERMANY, GHANA, GREECE, GUAM, HONDURAS, HONG KONG, INDIA, INDONESIA, IRAQ, IRELAND, ITALY, IVORY COAST, JAPAN, JORDAN KAZAKHSTAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MALI, MOSCOW, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORTHERN IRELAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SERBIA AND MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, THE NETHERLANDS, TIBET, TURKEY, UKRAINE, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM,  AND YEMEN
Software for Vitrea,  Vitrea fX, and  Vitrea Enterprise Suite (VES):    VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2      VPMC-09346B Vitrea fX   Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2      VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.    The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2.
Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite.  This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions.
Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
Myocardial Heart Wires   Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056  Model Number TME64S, Lot #C1-07057  Model Number TME64S, Lot #C1-07058  Model Number TME64S, Lot #C1-07111  Model Number TME64S, Lot #C1-07112  Model Number TME64S, Lot #C1-07113  Model Number TME64S, Lot #C1-07114  Model Number TME64S, Lot #C1-07122  Model Number TME64S, Lot #C1-07123  Model Number TME64S, Lot #C1-07124  Model Number TME64S, Lot #C1-07125  Model Number TME64C, Lot #C1-07143  Model Number TME64S, Lot #C1-07151  Model Number TME64S-3, Lot #C1-07156  Model Number TME65S, Lot #C1-07174
Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
Worldwide Distribution and US (nationwide) in the following states:  AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106   Product Usage: Samaritan 300/300P PAD  is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs:  Unconsciousness  Not breathing  Without circulation
Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed:  Issue 1 (On/Off Issue):  the device may turn itself on and off without input from the user.  When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device.  If the device does not detect that the audible prompts are followed (e.g., a patient is connected to the electrodes to allow the device to read the patient's ECG and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power.  this sequence of on-off events can happen repeatedly or intermittently.  If this condition is undetected, the battery will eventually become completely depleted.  In worst-case situations, it is possible that the battery could be depleted below the minimum battery capacity to allow for the delivery of therapy within a week.  However, a device experiencing this issue will be capable of delivering therapy provided that an adequate power source is available.  Devices potentially subject to this issue were manufactured between August 2004 and December 2010 and have a warranted life of up to 7 years.     Issue 2 (Battery Management Software Issue):  Certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery.  This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains.  This may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock.  If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device may not deliver a
Worldwide Distribution-USA (nationwide) and the countries of  Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests);  REF 03896216(10334837)(250 Tests) Not  CE Marked; OUS:  REF03204829(10310271)(50 Tests); REF  01157807(1 0314722) (250 Tests) CE  Marked; REF 09010686 (10340081)(250 Tests).    The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm,  Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France  +33 (0) 5.57.97.06.30  http://www.stryker.com  Distributed in the USA by Stryker Spine  2 Pearl Ct., Allendale NJ 07401-1677 USA  +1-201-750-8000    Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
Popcorn Indiana Aged White Cheddar Popcorn 0.8 oz - UPC 843571004233 3.5 oz- UPC 843571000532  8 oz- UPC 843571000785  8.3 oz - UPC 843571002956  9 oz - UPC843571000785    Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Various flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono. This recall was expanded to the consumer level once L. mono was confirmed in finished product.
Popcorn Indiana Bacon Ranch Popcorn Net Wt. 3.5 oz - UPC 843571001942  Net Wt. 7.75 oz - UPC 843571001935  Net Wt. 8.3oz. - UPC 843571001935  Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Various flavors of popcorn were manufactured on a conveyor belt which tested positive for L. mono.
Popcorn Indiana American Cheese Popcorn Net Wt. 7 oz. UPC 843571004134  Distributed by  Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Drizzled Cinnamon Sugar Kettlecorn Net Wt. 5.5 oz. UPC 843571003052  Net Wt. 6 oz UPC 843571002352  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Almond Biscotti Caramel Popcorn Net Wt. 6.5 oz. UPC 843571003809  Net Wt. 7 oz UPC 843571003854  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Apple Crisp Popcorn Net Wt. 6.5 oz. UPC 843571003243  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Drizzled Black & White Kettlecorn Net Wt. 6 oz. UPC 843571002345  Canada - Drizzled Black & White Kettlecorn Marbre Noir & Blanc Mais A Marmite  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Caramel Popcorn Net Wt. 7.4 oz. UPC 843571003045  Net Wt. 8 oz - UPC 843571002369  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Roasted Peanut Caramel Popcorn Net Wt. 7 oz, UPC 843571003861  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Chocolate Peanut Butter Kettlecorn Net Wt 5 oz. UPC 843571003786  Net Wt. 5.5 oz  UPC 843571003847  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Dark Fudge Chocolate Chip Kettlecorn Net Wt. 5.5 oz, UPC 843571003076  Net Wt. 6 oz UPC   Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Kettlecorn Net Wt. 9.75 oz UPC 84357100050  Net Wt. 14 oz. UPC 843571000693  Net Wt. 8 pack bag 0.7 oz. UPC 843571001676  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Salt and Pepper Popcorn Net Wt. 6.9 oz UPC 843571003557  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Popcorn Indiana Wasabi Reserve Popcorn Net Wt. 5.5 oz UPC 843571002048  Popcorn Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA
Nationwide and Canada through online ordering www.harryanddavid.com/h/home and through retail stores located throught the U.S.
Harry & David Crunchy Almond and Peanut Butter, 12 oz. jar., labeled in part: ''HARRY & DAVID CRUNCHY ALMOND AND PEANUT BUTTER***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED ALMONDS, ROASTED PEANUTS, SEA SALT.***MADE FOR HARRY AND DAVID MEDFORD, OR 97501***7 80994 73873 7***''   The 12 oz. jars are sold individually and also as gift add-ons for gift baskets.     The gift baskets are listed below:    Harry & David Apple Snack Box;  Wolferman's Bee Sweet Gift Basket;  Wolferman's Hearty Snack Gift Basket;  Wolferman's All-Day Assortment Gift Basket;  Wolferman's Fathers Day Basket
Best By Date on the recalled nut products - 01MAY11 through 24SEPT13.   The lot code format for the baskets is DDDYM(H or C), with DDD representing the Julian date, Y representing the year, and letter M, H or C representing the production facility, printed on the shipping container.  The affected lots would have been between 1460M(H or C) to 2682M(H or C).
Product received from supplier is being recalled due to the potential to be contaminated with Salmonella
Harry & David Creamy Banana Peanut Spread, 12 oz. jars labeled in part: ''HARRY & DAVID CREAMY BANANA PEANUT SPREAD***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED PEANUTS, SUGAR, BANANA COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 73871 3***''   The 12 oz. jars are available and sold individually and also as gift add-ons for gift baskets.     The gift baskets are listed below:    Harry & David Apple Snack Box;  Wolferman's Bee Sweet Gift Basket;  Wolferman's Hearty Snack Gift Basket;  Wolferman's All-Day Assortment Gift Basket;  Wolferman's Fathers Day Basket
Harry & David Creamy Caramel Peanut Spread, 12 oz. jars, labeled in part: ''HARRY & DAVID CREAMY CARAMEL PEANUT SPREAD***NET WT 12 OZ (340g)***INGREDIENTS: ROASTEDPEANUTS, SUGAR, CARAMEL COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 75786 8***''   The 12 oz. jars are sold individually and also as gift add-ons for gift baskets.     The gift baskets are listed below:    Harry & David Apple Snack Box;  Wolferman's Bee Sweet Gift Basket;  Wolferman's Hearty Snack Gift Basket;  Wolferman's All-Day Assortment Gift Basket;  Wolferman's Fathers Day Basket
Harry & David Creamy Raspberry Peanut Spread, 12 oz. jars, labeled in part: ''HARRY & DAVID CREAMY RASPBERRY PEANUT SPREAD***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED PEANUTS, SUGAR, RASPBERRY COMPOUND***MADE FOR: HARRY AND DAVID MEDFORD, OR 97501***7 80994 73872 0***''   The 12 oz. jars are sold individually and also as gift add-ons for gift baskets.     The gift baskets are listed below:    Harry & David Apple Snack Box;  Wolferman's Bee Sweet Gift Basket;  Wolferman's Hearty Snack Gift Basket;  Wolferman's All-Day Assortment Gift Basket;  Wolferman's Fathers Day Basket
Worldwide distribution: USA (nationwide) and country of Canada.
MOSAIQ   MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Worldwide Distribution - USA (nationwide)  and Internationally to  Canada,  Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
Hip Components: INSERT MOBILE ''COLLEGIA'' TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE ''COLLEGIA'' TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX ''COLLEGIA'' T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL ''PROCOTYL(R) E'' SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL ''PROCOTYL(R) E'' SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL ''PROCOTYL(R) E'' SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL ''PROCOTYL(R) E'' SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL ''PROCOTYL(R) E'' SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL ''PROCOTYL(R) E'' SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL ''PROCOTYL(R) E'' SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL ''PROCOTYL(R) E'' SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION ''PROFEMUR(R) Z'' SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION ''PROFEMUR(R) Z'' SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION ''PROFEMUR(R) Z'' SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION ''PROFEMUR(R) Z'' SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION ''PROFEMUR(R) Z'' SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION ''PROFEMUR(R) Z'' SI
INSERT MOBILE ''COLLEGIA'' TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE ''COLLEGIA'' TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX ''COLLEGIA'' T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL ''PROCOTYL(R) E'' SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL ''PROCOTYL(R) E'' SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL ''PROCOTYL(R) E'' SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL ''PROCOTYL(R) E'' SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL ''PROCOTYL(R) E'' SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL ''PROCOTYL(R) E'' SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL ''PROCOTYL(R) E'' SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL ''PROCOTYL(R) E'' SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION ''PROFEMUR(R) Z'' SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION ''PROFEMUR(R) Z'' SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION ''PROFEMUR(R) Z'' SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION ''PROFEMUR(R) Z'' SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION ''PROFEMUR(R) Z'' SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION ''PROFEMUR(R) Z'' SIZE 8, PHA00616,
W06335038, W12383096, and X07419109 VIS A COTYLE D5.5 L=15 ''ANCA'' , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 ''ANCA'' , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 ''ANCA'' , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR ''ANCA'' SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 ''ANCA'' , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 ''ANCA'' , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 ''ANCA'' , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 ''ANCA'' , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 ''ANCA'' , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION ''ULTIME'' HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM ''ULTIME'' STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM ''ULTIME'' STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM ''ULTIME'' STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM ''ULTIME'' STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503,
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Knee Components: ROTULE ''913'' D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL ''913 PCR'' T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL ''913 PCR'' T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL ''913 PCR'' T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL ''913 PCR'' T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL ''913 PCR'' T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL ''913'' T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL ''913'' T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL ''913'' T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL ''913'' T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE ''913'' D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE ''913'' D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE ''913'' D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE ''913'' D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE ''913'' D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. ''913'' D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. ''913'' D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE ''913'' T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE ''913'' T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL ''913 RS'' T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL ''913 RS'' T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL ''913 RS'' T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL ''913 RS'' T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL ''913 RS'' T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL ''913 MP'' T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG ''FPV EVOS'' RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATE
ROTULE ''913'' D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL ''913 PCR'' T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL ''913 PCR'' T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL ''913 PCR'' T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL ''913 PCR'' T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL ''913 PCR'' T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL ''913'' T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL ''913'' T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL ''913'' T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL ''913'' T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE ''913'' D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE ''913'' D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE ''913'' D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE ''913'' D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE ''913'' D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. ''913'' D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. ''913'' D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE ''913'' T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE ''913'' T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL ''913 RS'' T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL ''913 RS'' T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL ''913 RS'' T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL ''913 RS'' T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL ''913 RS'' T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL ''913 MP'' T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG ''FPV EVOS'' RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG ''FPV
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers:  U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985  PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986  PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers:  X06391315, X07401150, X07420387, and X09401447  PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers:  W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988  TIGE HUMERALE PROXIMALE ''NGR'' LONG, Part Number PPP70088, Lot Number X01359005    Orthopaedic
PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers:  U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986  PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers:  X06391315, X07401150, X07420387, and X09401447  PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers:  W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988  TIGE HUMERALE PROXIMALE ''NGR'' LONG, Part Number PPP70088, Lot Number X01359005
Nationwide Distribution including IL, OH, NY and TN.
Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.    The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Adult Resuscitator, Pro-5000 Series, Single Patient Use,     The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Product List 071012, Product Code: PRO-5009P, Lot #102217.
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use,     The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028   The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028    The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.
The recall affected Xan Confections products distributed through 98 stores in California, Arizona, Nevada, Oregon, Washington, Texas, Alabama, Louisiana and Nova Scotia (Canada), as well as through online distribution.
Mini BigMouth: Chocolate, confections. 1) Bulk Milk Mini BigMouth, item number 093. 15 pieces per case; 2) 4-Piece Mini BigMouth, item number 284, 48 pieces per case: 3) 6-Piece Mini BigMouth, item number 002, 72 pieces per case
The firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learining that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Chocolate, confections. Bulk Dark Mini BigMouth, item number 094. Each case contains 15 pieces.
Chocolate, confections. Bulk Peanut Butter LadybuG, item number 296.15pieces per case.
Chocolate, confections. Bulk Peanut Butter Crunch LadybuG, item number 090. 15 peices per case.
Chocolate, confections. Bulk Mini Peanut Butter Crunch LadybuG, item number 115. 24 pieces per case.
Chocolate, confections. Bulk Peanut Butter Jewel, item number 096. 24 pieces per case.
The firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 throught September 24, 2012.
Chocolate, confections. Bulk Milk BigMouth, item number 233. 8 piece per case.
Chocolate, confections. Bulk Dark BigMouth, item number 232. 8 peices per cases.
Chocolate, confections. Bulk Dark Peanut Butter Cup, item number 273. 24 pieces per case.
The firm voluntarily recalled 13 of its gourmet peanut butter chocolate products because they have the potential to be contaminated with Salmonella, upon learning that Sunland, Inc., the peanut butter supplier used in the production of Xan Confections, has recalled its entire peanut butter product from May 1, 2012 through September 24, 2012.
Chocolate, confections. Bulk Milk Peanut Butter Cup, item number 254. 24 pieces per case.
Chocolate, confections. Packaged in gift box cartons. 4-Piece Peanut Butter Truffles, item number 079. Labeling reads in part:''ALL NATURAL LadybuG Peanut Butter truffles*** www.XanConfections.com Distributed by: Xan Confections Irvine, CA 92614 U.S.A.***''.   4 pieces in each gift box @ 12 in a case  total  48 pcs
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani,  6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.
UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon,  6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403
Worldwide distribution: USA (nationwide) including states of : MI and NY; and countries of: Belgium, Canada, Japan, India, Russia, United Arab Emirates.
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.   The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel .  An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display.  The flow and pressure display information may also be incorrect after the malfunction.
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954.   The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
Nationwide Distribution including  AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and  UT.
ILLlCO MIS Posterior Fixation System,  Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation  Orthosis, Spondylolisthesis Spinal Fixation      The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Product Codes: KW, MNI, MNH.   Part NumberlLot Number:  PART DESCRIPTION LOT       7384S-30    Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm    646501          73845-35    Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm    646502       73845-40    Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm    646503       73845-45    Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm    646504       73855-35    Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm    646510       73865-30    Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm    646515       73865-35    Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm    646516       73865-40    Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm    646517       73865-45    Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm    646542       73865-50    Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm    646543       73875-35    Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm    646546       73875-45    Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm    646548       73875-50    Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm    646549
The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti  Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Worldwide Distribution--US (nationwide) and the country of: Canada, Deuche, France, Greece, Mexico, Israel, and Japan.
West Nile Virus IgG DxSelect'' kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen  Wells, Catalog Number EL0351, Lot Number 121117.    510(k) No. K031953    The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection.
Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen  Wells, Catalog Number EL0351, Lot Number 121117.
The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.
Ma Baensch Marinated Herring in Wine Sauce, Net Wt. 24 oz.. (680g), UPC 714449-10220 in glass jars with gold metal lids.
Sell By Date and Lot Code:  BEST IF USED BY 06NOV12 158.  (printed in black ink on the top of the gold lid)
Labeling error.  One date code of  24 oz. Baensch Marinated Herring in Wine Sauce may contain an undeclared milk allergen.
Product was shipped to the following states: IN, MI, OH & WV.
Peanut Butter Ice Cream (1.75 Qt & Half Gallon) Peanut butter ice cream with a peanut butter ribbon and a delightful crunch candy Artificial flavor added MFD. BY SMITH DAIRY PRODUCTS COMPANY, ORRVILLE, OHIO 44667 1-800-778-7078.  Sold under the following names: SMITH'S Peanut Butter Crunch Ice Cream, Acme Peanut Butter Twist Ice Cream & SD Peanut Butter Crunch Ice Cream
4,368/1.75 qt containers, 90,804/half gallon containers & 2,309/3 gallon tubs
The firm was notified by their supplier, Pecan Deluxe, Dallas, TX, that the peanut butter crunch candies that was purchase for use in their ice cream were made using peanut butter supplied from Sunland, Inc.
SD Peanut Butter Brownie Crunch 3 Gallon MFD. BY SMITH DAIRY PRODUCTS COMPANY, ORRVILLE, OHIO 44667 1-800-778-7078.
California, Idaho, Montana, Nevada, North Dakota, Oregon, Utah, Wyoming, Washington.
Albertsons Brand Peanut Butter Chocolate Ice Cream, 1.5 Quarts (1.42L), commonly called a 48 fl oz container.       Peanut Butter Chocolate Ice Cream (Chocolate ice cream with a peanut butter swirl); 1.5 QTS (1.42L), (UPC Code:  0 41163 45903 8 for Albertsons Peanut Butter Chocolate)      Packaged in paper cardboard round oblong container. Labeled with a.   Buena Park (IMS Plant Number  06-20). Labeled as ''Distributed by SUPERVALU INC. Eden Prairie, MN 55344''.
Buena Park (IMS Plant Number  06-20)    06-20 1024 RA (plant code, 24 hour time, operator initial)     MFG 10/08/12 EXP 10/08/13 LOTE A (manufacturing month, day, year , expiration month, day, year, lot number)   Code date is injected on the bottom of container in black ink.       UPC Code:  0 41163 45903 8 for Albertsons Peanut Butter Chocolate and 0 41163 45891 8 for Albertsons Peanut Butter Cup
. This recall was initiated because the affected products contain a peanut butter ingredient supplied by Sunland, Inc. which may be contaminated with Salmonella. The peanut butter manufacturer Sunland recently expanded its nationwide product recall.
Albertsons Brand Peanut Butter Cup Ice Cream, 1.5 Quarts (1.42L), commonly called a 48 fl oz container.       Peanut Butter Cup Ice Cream,  (Vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls); 1.5 QTS (1.42L), (UPC Code 0 41163 45891 8 for Albertsons Peanut Butter Cup)    Packaged in paper cardboard round oblong container. Labeled with a.   Buena Park (IMS Plant Number  06-20). Labeled as ''Distributed by SUPERVALU INC. Eden Prairie, MN 55344''.       06-20 1024 RA (plant code, 24 hour time, operator initial)       MFG 10/08/12 EXP 10/08/13 LOTE A (manufacturing month, day, year , expiration month, day, year, lot number)       Code date is injected on the bottom of container in black ink     UPC Code:    0 41163 45891 8 for Albertsons Peanut Butter Cup
Mega Raw Oriental Produce Wholesaler- Valencia Peanuts, No UPC, Item numbers M10101.
Identified with Best By Dates October 12, 2012 through October 12, 2013.
Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella.  On October 12, 2012 the firm extended its recall to include Raw and Roasted Shelled and In-Shell Peanuts.
Mega Raw Oriental Produce Wholesaler- Virginia Peanuts, No UPC, Item numbers M76101.
Natural Value Raw Peanuts, 30 lb Item number 910169.
Sunland Roasted Valencia Peanuts, 2 oz, UPC 48687112166.
Identified with Best By Dates October 12, 2012 through April 12, 2013.
Sunland Salted and Roasted Valencia Peanuts, 1 lb, UPC 48687122066.
Sunland 100% Organic Raw Valencia Peanuts, 1 lb, UPC 48687182060.
Sunland Organic Raw Inshell, 25 lb, UPC 10107.
Sunland Organic Roasted In Shell Peanuts, 25 lb UPC 11109, 2 lb UPC 48687791057.
Sunland Raw Organic Valencia Peanuts, 50 lb UPC 4868700103
Sunland Raw In-Shell peanuts, 50 lb UPC 0-48687-10101-6 .
Sunland Raw Shelled Organic Peanuts, 30 lb Item 403.
Sunland Raw Shelled Peanuts, 50 lbs, Item 400.
Sunland Raw Valencia Peanuts, 25 lb Item 104; 1 lb UPC 0-48687-10206-8; 2 lb UPC 0-48687-10215-0.
Sunland Raw Valencia Peanuts - Export, 50 lbs UPC 4868700101.
Sunland Raw Virginia Reg Jumbo InShell, 50 lb UPC 0-48687-76101-2
Sunland Roasted In Shell Peanuts, 25 lb, UPC 0-48687-11102-2
Sunland Salted In-Shell Bulk in Box, 25 lb UPC 0-48687-12108-3.
Sunland Salted In Shell Bulk Organic in Box, 25 lb UPC 0-48687-12110-6.
Sunland Salted Organic Peanuts, 1 lb UPC 0-48687-20206-5
Sunland Shelled Raw Valencia Peanuts 3 lb UPC 0-48687-13212-6.
Sunland Shelled Roasted Valencia Peanuts, 18 oz, UPC 0-48687-14909-4.
Sunland Shelled Salted Valencia Peanuts, 18 oz, UPC 0-48687-15909-3.
Sunland Shelled Split Peanuts, 50 lb Item 401.
Sunland Valencia Roasted & Salted Peanuts, 2lb UPC 0-48687-12105-2.
The Nut Shop Roasted Valencia Peanuts, 7 oz, Item 22601.
The Nut Shop Salted and Roasted Valencia Peanuts, 7 oz, Item 22602.
Torn and Glasser Salted Roasted Jumbo Virginia, 50 lb, Item 533.
Treasured Harvest Valencia Peanuts, 50 lb item 212.
Varian Medical Systems, Inc. Oncology Systems
Worldwide Distribution - Nationwide(USA) and including the countries of Australia, Denmark and the United Kingdom.
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.