Recalling Firm
Upstate New York Transplant Services, Inc.
Implant Direct Sybron Manufacturing, LLC
Whole Foods Market Northeast Regional Office
Aurora Area Blood Bank Dba Heartland Blood Centers
PerkinElmer Life and Analytical Sciences, Wallac, OY
Northern California Community Blood Bank
Blood Centers of the Pacific - Irwin Center
Lifesouth Community Blood Centers - Montgomery Region

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

Distribution Pattern
Domestic: CA, CO, CT, FL, IL, KY, LA, MA, MD, ME, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TX, UT; VA, WA, WI, & WY; Foreign: CHN & COL.
U.S. distribution to the following; nationwide including Puerto Rico.
NATIONWIDE US ARGENTINA AUSTRALIA AUSTRIA BRAZIL CANADA CHILE CHINA COSTA RICA ECUADOR GREECE INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO NETHERLANDS PANAMA POLAND SINGAPORE THAILAND
AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MI, MN, MO, MS, MT, NC, NE, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY
Product was distributed to the following states: IL, IN, KY, MI & OH.
Nationwide. Foreign: Belgium Germany France Netherlands
Nationwide in USA, ** Internationally- Canada, Curacao
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Worldwide Distribution - US Nationwide and the countries of Denmark, Brazil, Croatia and Germany
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Distributed throughout the United States
MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
The product was distributed in the US as well as the following foreign countries: Guam and Puerto Rico, Israel, Kuwait, Trinidad and Tobago
U.S. distribution to the following; CA, VA, AZ, MN, TX, LA, NC, NH, NY, IL, NJ, MI, AK, ND, WA, ME, FL, OK, MA, CO, TN, MD, RI Foreign distribution to the following; Japan, Philippines, Bermuda.
US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria
Distributed throughout the United States.
Distributed to a sole distributor in NC.

Product Description
Naturally Creative; 3 Bean Medley Salad; Net Wt. 10 lb. or Net Wt. 4 LB. 10 l
Wegman's Five Bean Salad; Net wt. 10 LB.
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Balanced Guru Antioxidant Masque, Organic Spiced Up Berries Antioxidant Facial Masque. Sold as 4 oz. and 1 oz..
Balanced Guru Moisturizing Masque, Organic Aloe, Lotus & Chamomile. Sold as 8 oz., 4 oz., and 1 oz..
Balanced Guru Astringent Masque, Organic Citrus and Kelp Facial Masque. Sold as 4 oz. and 1 oz. m
Stags Leap Winery Collection Basket #752
Tis The Season gift basket, Item No. 1084804
Cakebread Cellars Napa Valley Duet Basket #396
Vintners Path Merlot Seasons Greetings Basket #724
The Ultimate Wine and Champagne Collection Basket #399
Bodega de San Antonio Sangria Traditional Basket #298
Grgich Hills Napa Valley Selection Basket #713
The Executive with Houdini Blue Cheese Twists, 7 ounces COM 659 SKU# 54002-3, SKU#54087-0
Napa & Sonoma Valley Exclusive Basket #141
Metal Basket with Handles with Houdini Blue Cheese Twists, 7 ounces COM 659, SKU# 54316-1
Vintners Path Cabernet Seasons Greetings Basket #763
Sauvignon Blanc and Cabernet Collection Basket #446
Houdini Napa Valley Collection Basket #766
Sweets For The Season gift basket, Item No. 1081594
Alfasi Chardonnay Kosher Selection Basket #847
Wooden Centerpiece gift basket, Item No. 1080571
Houdini Fabric gift basket, Item No. 1072552
Vintners Path Chardonnay Seasons Greetings Basket #795
Metal Basket with Leather Handles SKU #54506-6
California Cabernet and Chardonnay Gift Basket #361
Alfasi Cabernet Kosher Selection Basket #810
Woven Lacquer Treat Basket with Blue Cheese Savory twist item, SKU# 55263-7,
Hot Cocoa, NOT FOR RETAIL SALE, Prod: 28OCT2016, BB: 28JUN2017, Net Weight: 907 g (2.0 lb), Best Before: 28JUN2017
50423 Madison Hot Cocoa WIP; Production date 11/30/16
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box.
Blood and Blood Products for Reprocessing
Chocolate Premium Chocolate Treats Vanilla Caramels packaged under the following labels: (1) Weigel's Mountain Valley Premium Chocolate Treats Milk Chocolate Vanilla Caramels, 2.75 oz (78g) Tube snack Bag UPC Code: 024354705039; (2) Royal Farms Market Place Premium Chocolate Treats Milk Chocolate Vanilla Caramels 2.75 oz (78g) Tube snack Bag UPC Code: 483743202045
Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE , NET WT 4 LB 13 OZ, KEEP FROZEN, UPC 021130 114641, Product Code 06620 ---
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy strawberries & cream ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 04776 1 (retail), Product Code 04776 --- Rich Products Corp., Buffalo, NY 14213
RICH'S 1/4 Sheet White Cake with Vanilla Ice Cream Cake, KEEP FROZEN, UNIT NET WT: 60 OZ (3 LB 12 OZ), COUNT: 4 x 1/4 SHEET CAKES, NET CASE WT: 15 LB, UPC 049800 290013 (retail), Product Code 29001 --- RICH PRODUCTS CORP BUFFALO, NY 14213
Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy vanilla ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 62878 6 (retail), Product Code 62878, and UPC 0 49800 02453 3 (retail), Product Code 02453 --- Rich Products Corp., Buffalo, NY 14213 ,1/4 SHEET VANILLA ICE CREAM CAKE WITH WHITE CAKE LAYERED ICE CREAM CAKE, NET WT 18 LB, 4 UNITS/4 lb 8 oz, Product Code 00180
Mikesell's Nacho Cheese FLAVORED TORTILLA CHIPS 2.25 OZ (64g) bag UPC 0 71104 00554 3
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Apheresis Red Blood Cells, Leukocytes Reduced
Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 OZ. (85g), UPC Code: 41224714021 and Case UPC Code: 10041224714028, Item # 71402, PRODUCT OF SPAIN
Raley'ss Canned Cut Green Beans 14.5oz ; UPC: 4656700204
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
Whole Foods Markets Lobster Bisque Distributed by: Whole Foods Market, Englewood Cliffs, NJ 07652 UPC: 8-80632-00100
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Kings Pastry Chocolate Bar Cake, 1050 g. Frozen Product Code: 10135 UPC: 685961101357
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
Nepro Vanilla High Protein , 8oz metal can
Promote with Fiber Vanilla, 8oz metal can
Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
The Honest Co. Organic Baby Powder Net Wt. 4.0 oz. (113 g) UPC Code: 817810014529
The Honest Co. Diapering Essentials UPC Code: 0817810027185 Containing Organic Baby Powder Net Wt. 4.0 oz. (113 g)
Snacking Favorites Organic Veggies with Organic Ranch Dip. 16.25 oz. plastic tray (1.02 lb.) UPC barcode: 71651901471 - this is the incorrect barcode that is on the bottom of recalled product. Correct UPC: 716519014765 Incorrect Allergen Statement: Egg. Milk Correct Allergen Statement, Egg, Milk, Soy and Mustard.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India.
Hemp & Grain Co., Organic Pea Protein 80%, Net Weight 44.1 lbs. Paper bags, 36 paper bags/pallet.
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787 27788 27789 27794 27812 27814 27815 27816 27817 27818 27820 27821 27822 27823 27824 27825 27827 27828 27830 27831 27832 27848 27864 27867 27868 27888 27903 27922 27823 27924 23042 27925 27926 27927 27932 27933 42335 42355 42365 42836 42856 42866 44420 44421 44430 44465 46070 46075 46080 46085 46635 46655 46665 46836 46856 46866 46871 46876 46881 46886 92355 92365 92856 92866 96655 96665
Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
Syngo.plaza, picture archiving and communications system.
Los Chileros, Basil Pesto, Net Wt. 6 oz. (170g). plastic shell container. Keep Refrigerated
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.

Product Quantity
b. tubs: 560 lbs; 28 cases, 2-10lb tubs/case Prod
42,776 unit dose cups and 17,403 bottles
32,027 bottles and 16,310 unit dose cups
4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
659,957 Total Units (249,570 units domestically & 410,387 units internationally)
1379 kits (190 kits in U.S.A and 1189 Kits internationally) in total
24 instruments and 3 spare disk remover modules

Reason for Recall
uct may be contaminated with Listeria monocytogenes. 01/2
Product may be contaminated with Listeria monocytogenes.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Possible contamination of product with Salmonella due to incorporation of powdered milk and powdered buttermilk .
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
Organ preservation fluid recalled due to potential for bacterial contamination.
West Coast Laboratories is recalling Xambo and Devagrass because there may be presence of 1,3-dimethylamylamine (DMAA).
Blood product, did not meet the acceptable product specifications for release, was distributed.
Blood products, collected from a donor at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
The product may contain undeclared walnuts from intermediate layer cake supplier.
The firm was notified by their contract manufacturer that they received ingredients that may be contaminated with Salmonella.
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Apheresis product, collected from a donor who was allowed to donate without a current physical, was distributed.
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
Blood products, collected from an ineligible donor, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, in which donor suitability was not adequately determined, were distributed.
Apheresis products, collected from an unsuitable donor due to a donor screening deviation, were distributed.
Product quality issue. Through sampling, FDA revealed the presence of non-pathogenic Gram Positive Rods (microorganisms).
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
In response to a consumer complaint, Investigation by the manufacturer determined that a partial black rat was found in the product.
Blood products, which did not meet acceptable product specifications, were distributed.
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Failed Dissolution Specifications; 18 month stability time point
Back label of Lobster Bisque product was mislabeled as Butternut Squash Soup (which contains fewer allergens [only milk] than the Lobster Bisque [milk, shellfish, wheat])
Product sterility compromised due to breach of sterile barrier
Blood product, with a low pH, was distributed.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
The product is being recalled due to incidence and reports of the product breaking during surgery.
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
Product contains undeclared hazelnut (allergen)
The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
The firm expanded recall to include additional batches. Product recalled because of off odor and taste due to microbial contamination.
There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
Blood products, identified as unsuitable due to a donor screening deviation, were distributed.
Blood product, in which donor suitability was not adequately determined, was distributed.
Mann Packing was notified by a customer that the incorrect bottom label is on their Organic Veggie Tray with Best By date of January 14, 2017 and does not declare the allergens of egg, milk, soy and mustard.
It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.
Platelet product, for which QC was unacceptable, was distributed.
Blood product, collected from a donor for whom eligibility was incorrectly determined, was distributed.
Platelet products, for which WBC quality control was not performed, were distributed.
Del Dee Foods, Inc.withdrew Lot# PP33116-0-D after receiving a report of salmonella found in two sample tests taken from product in the above lot before it reached the consumer.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image.
Software update for improvements and to resolve several issues
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, for which a unit received inadequate additive solution, was distributed.
Plateletpheresis product that did not meet specifications, was distributed.

Code Info
Lot Code: AR07047EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 AL 07 ; Lot Code: AR08047EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 AL 08 ; Lot Code: AR27097EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 SE 27 ; Lot Code: AR29067EA1, Carton Code: BEST BEFORE/MEILLEUR AVANT 17 JN 29 ; UPC: 6 44209 02223 6
Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ; Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018 Batch / Lot Number: PBR-0074-337 Batch / Lot Number: PBR-0060-386
Retail: Best By JUN-26-2017, JUL-18-17, AUG-01-17 (Best By date code found on side of each individual unit package); -- Product Code 06620: Julian Dates 14076273, 14076295, 14076309
Retail: Best By JUN-27-17, JUL-15-17, JUL-23-17, JUL-28-17, AUG-27-17 (Best By date code found on side of each individual unit package); -- Product Code 04776: Julian Dates 14076274, 14076292, 14076300, 14076305, 14076335.
Retail: Best By OCT-20-17, NOV-01-17 (Best By date code found on side of individual unit package); Product Code 29001: Julian Dates 14076294, 14076306.
Retail UPC 049800 628786: Best By JUL-29-17; Product Code 62878: Julian Date 14076306; -- Retail UPC 049800 024533: Best By Dates JUN-25-17, JUL-23-17, JUL-29-17 (Best By date code found on side of each individual unit package); Product Code 02453: Julian Date 14076300, Product Code 00180: Julian Dates 14076272, 14076306
Sell by dates: February 0217 and February 1617
Lot No. 95 Production Codes: P1201 Expiration Date: December 1, 2018; and P1130 Expiration Date: November 30, 2018
Lot Code: I5EG162A ; Best By Date: Dec 2018
Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
Lot Numbers: 1) 0336 - Expiration date 2017-01-31 2) 0337 - Expiration date 2017-02-28 3) 0338 - Expiration date 2017-05-31
Lot Numbers: 1) D01196 - Expiration date 2016-12-31 2) D0120 - Expiration date 2017-03-31
All codes where hazelnut and/or tree nuts are not declared on the label
Lot Number 57648RA00 Expiration Date 1Jan1017
Lot Number 57420RA00 Expiration Date 1Oct 2016
Lot Number 57643RA00/01/02 Expiration Date 1Oct 2016
Lot Number 57447RA00 Expiration Date 1Oct2016
Lot Number 59879RA00 Expiration Date 1Dec2016
Lot Number 57648RA11 Expiration Date 1Jan 2017
Best if Used by: January 14, 2017; Lot Serial # 3658366