Recalling Firm
Whole Foods Market South Seafood Distribution
Lifesouth Community Blood Centers - Montgomery Region
American National Red Cross, Penn Jersey Region
American National Red Cross SW Region - HT
Maui Soda & Ice Works Ltd/dba Roselani Ice Cream
Brookfield Prescription Center Inc. dba MD Custom Rx

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
Worldwide Distribution - US including the states of CA, CO, FL, IL, NC, NJ, OH and PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom.
Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.
US: Nationwide (FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA, WA)
US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
Worldwide Distribution -- USA, including the states of AK, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Australia, Brazil, Canada, China, India, Indonesia, Japan, Korea, Kuwait, Mexico, Netherlands, Pakistan, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Nationwide Distribution including North Carolina and Maine
US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
Distributed in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Nationwide Distribution: USA including states of: FL, IL, CA, CT, NC, OH, TX, WA, NH, PA, MI, IN, GA, IA, LA, MS, AZ, SC, NV, and NY.
Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.
Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
US Nationwide in the states WI, NC, FL, IL, TX, NC, CO, GA, and PA
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
Alabama, Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, North Dakota, New York, North Carolina, Ohio, Oklahoma, Texas, Virginia and Wisconsin
Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
Nationwide in US: UT, CA , AZ, NJ, MD, FL, GA, IL, TX Worldwide to: Canada
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.
US Nationwide Distribution in the states of CA, PA, and TX
Worldwide Distribution - USA nationwide including DC and Puerto Rico, AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.
US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.
Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.
Worldwide Distribution - USA including PR. DC, GUAM, all states except VT. Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
The firm distributed to one firm in Indiana
Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.

Product Description
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Jardines 7J Queso Amarillo (Item#50100) ; label: Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
DL Jardines Queso Loco (Item#R5230) ; Label: Special Edition D. L. Jardine's Texas Ranch Recipes Queso Loco Cheese Salsa & Dip; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
Mi Queso, Su Queso (Item#50440) ; Label: Jardine's 7J Ranch Mi Queso, Su Queso; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
HT Traders Medium Queso (Item#HT510) ; Label: Medium Queso; Premium Salsa; Net Wt. 16 oz. Distributed by Harris Teeter, Matthews, NC
Three Compadres Gift Box containing a varying combination of three Jardine products in 16 oz. glass jars. Some Gift Boxes included one jar of either Jardine's 7J Ranch Mi Queso, Su Queso (See Product #3) or one jar of Queso Loco Cheese Salsa & Dip (See Product #2)
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette
Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4
Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)
Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Simplexa'' Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa'' Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Red Blood Cells (Apheresis) Leukocytes Reduced
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat
Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container Ingredients; Contains Jonah Rock Crab Meat, Salt
Ocean's Catch Jonah Crab Minced Meat Crabmeat , Net WT. 10 lb. plastic bag
Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors.
Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch flavors
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
Blood and Blood Products for Reprocessing
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg)
Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion.
Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC 41498-20371
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Ocean Spray Greek Yogurt Covered Craisins Dried Cranberries , 8 oz Resealable Pouch UPC: #23719
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI
waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327
Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998. Packaging includes a PET bottle. The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and back) information is superimposed over an antique map in various shades of brown.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Dole Garden Soup ''Roasted Garlic Tomato Basil'', Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
MIS Rod 2, a component of the NewPort System Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol.
Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2. Central Markets in 8 oz cups with snap on lid (27056). 3. Cobblestone Market in 5 lb. pail (42403) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442)
Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), and 5 lb. (11951) white tub with snap on lid; 2. 150+Central Markets in 8 oz cups with snap on lid (27057). 3. Cobblestone Market in 5 lb. pail pails with snap on lid (42503). 4. Dierks Waukesha in 5 lb. pail with snap on lid (11952).
Olivia Swan Cheddar Cold Pack Cheese 10 lb. pail with snap on lid (12341os)
Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid (42550); 2. Cobblestone Market in 5 lb. pail pails with snap on lid (42603).
Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid.
Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid.
Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid.
Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid.
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
Integra LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU 90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK 90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU Product Usage: The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic.
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT). Medical Device for imaging.

Code Info
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
All product distributed prior to 03/31/14.
Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.
lot number 101366 with a sell by date before 5/14/14; lot number 101507 with a sell by date before 5/20/14; lot number 101540 with a sell by date before 5/21/14
8oz :containers: lot number 101372 with a sell by date before 5/14/14; lot number 101432 with a sell by date before 5/19/14; lot number 101474 with a sell by date before 5/20/14; 16 oz containers: ''lot number 101372 with a sell by date before 5/14/14; ''lot number 101391 with a sell by date before 5/16/14; ''lot number 101407 with a sell by date before 5/16/14; ''lot number 101432 with a sell by date before 5/19/14; ''lot number 101474 with a sell by date before 5/20/14; ''lot number 101539 with a sell by date before 5/21/14.
syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
Lot Code 11914 / Best ByDate 10-26-14, and Lot Code 14314 / Best By Date 11-24-14
Best By Dates: Feb 10, 2015 and Feb 11, 2015
Expiration Date: October 28 2015 Lot #24273
Part numbers 550120 for standard; 550516 for S system and 550650 for Si System.
Part number 551184 - US Manual; Part number 550965 - OUs manuals.
Part number 551979 - da Vinci S, Si and SI-e Part number 551980 - da Vinci Standard.
Lot No. WF14113 and WF14114, Best By Oct 23 2015 and Oct 24 2015
Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278
DFU: 18-0047: Revisions A & B 18-0074: Revision A; and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A, and 19-0013: Revisions A, B, & C.
Lot No. Z21781A (45mm NewPort MIS Rod, 2) Z21956A (50mm NewPort MIS Rod, 2) Z21782A (55mm NewPort MIS Rod, 2) Z21957A (60mm NewPort MIS Rod, 2) Z21784A (75mm NewPort MIS Rod, 2) Z21958A (80mm NewPort MIS Rod, 2)
Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.
model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX
WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.
Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015.
Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.
Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.
Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.
Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.
Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.
CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.
There is no code information. The package shows the type of mice and the quantity.
30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015. 90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.

Product Quantity
9072 jars (or 856 cases each holding 12 jars)
720 cases (4 plastic barrels per case), 2,880 plastic barrels
a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
474 cs (9,480 ea) total for all kits involved.
474 cs (9,480 ea) total for all kits involved
Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511
26,530 30-Count Bottles; 14,597 90-Count Bottles

Reason for Recall
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.
Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.
Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a Hemoset containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
The product has the potential to be contaminated with Clostridium botulinum.
Firm received complaints of illness after consumption of Amberjack fish.
HK Galleria Wholesale is recalling Rice Porridge with Abalone because it may be contaminated with Clostridium botulinum.
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
Blood product, collected from a donor with polycythemia vera, was distributed.
Blood product, possibly contaminated with air during collection, was distributed.
Blood products, collected from an unsuitable donor, were distributed.
Blood product, which failed to meet the minimum specification for red blood cell percent recovery, was distributed.
Blood products, for which the monthly product quality control was outside the acceptable range, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, processed more than eight hours after collection, were distributed.
The external power supply input is overheating at the connection to the freezer.
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa'' Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.
Blood product, contaminated with air was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
Blood product, which tested positive for Fyb red cell antigen, but was previously typed as negative for Fyb antigen, was distributed.
Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed.
There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
Product contaminated with Listeria monocytogenes
Products contain ''Aegeline'' an unapproved New Dietary Ingredient.
A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as ''RUN-TEST''.
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Blood products, collected from a donor who reported a post donation illness, were distributed.
Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
Blood product, collected from a donor whose health history was not adequately performed, was distributed.
Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
This voluntary recall has been initiated because Savor Brands Large Pitted Kalamata Olives may contain glass.
Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom Cheese because the product is mislabeled. The product contains other type of mushroom instead of Morel Mushrooms as listed on the label.
A seasoning supplier is recalling its rosemary and olive oil seasoning blend, which potentially may be contaminated with Salmonella.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, which failed the residual white blood cell count and labeled as leukoreduced, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Complaint received of a carton of Roselani Tropics Kona Mud Pie Ice Cream that was filled with chocolate Macadamia Nut Ice Cream.
Pistachio flavored ice cream was inadvertently packed into 16 oz. (Pint) containers labeled as Thrifty Ice Cream Mint 'N' Chip. Ingredient statement does not declare pistachio.
National Vitamin is recalling Nature's Blend Ferrous Gluconate Tablets because they are mislabeled on the front panel with 65 mg of elemental iron. The side panel and the tablets inside the bottle have the correct label with 36mg of elemental iron per tablet.
Olde Thompson is recalling Kirkland Signature Coarse Ground Malabar Black Pepper because it may be contaminated with Salmonella.
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD) were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Laser cooling fans and internal fan of the associated fluidics cart are not operational.
Dole Packaged Foods is recalling Dole Garden Soup Roasted Garlic Tomato Basil because it contains undeclared milk.
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.
Tritanium Patella Inserter Instrument fracture during implantation. .
Parkers Farm is recalling cheese and salsa products that may be contaminated with Listeria monocytogenes. This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software. It could result in the original UI remaining in the tube which could be delivered into the next bag.
LED battery chargers may prematurely fail and will not charge the LED battery as intended
The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
The firm imitated a voluntary recall of frozen mice intended for use as reptile feed because of possible human exposure to Lymphocytic Choriomeningitis Virus from handling the mice.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
Flat Panel Display (FPD) failed to remain securely locked in the deployed position.