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

Distribution Pattern
Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malawi, Malaysia, Maldives, Mali, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Nigeria, North Yemen, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia (CIS), Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Lucia, Sweden, Switzerland, Tajikistan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks & Caicos, UAE, Uganda, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, and Zimbabwe.
distributed in AK, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OK, OR, PA, TX, UT, VA, WA, WI, WY.
distributed in AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, IA, MI, MN, NY, OR, SC, TX, WA and in Canada.
one distributor and two customers, all in WA state
Nationwide: AR, AZ, CA, DE, FL, HI, IA, ID,IL, IN, LA, MA, MD, ME, MT, ND, NE, NH, NM, NV, OR, RI, SD, TX, UT, VT, VA, WA, WY, including Washington DC
Product is distributed to Pennsylvania, New Jersey, Delaware, Maryland, and Virginia, Florida.
Nationwide - CT, CA, CO, FL, GA, IN, IL, KY, MA, MD, ME, MN, NC, ND, NE, OH, PA, SC, WV, VA, WI

Product Description
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Fuji apples, Nature's Delight brand, packaged in tray pack box size 64, net weight 40 lbs., PLU 4131, distributed by L&M Yakima, WA 98903
Bristol Farms Tasty Treats -Nonpareils Milk Chocolate; 5 oz. plastic pouch; UPC 7 97299 00476 4 Ingredients (incorrect): dark chocolate coating [sugar, chocolate liquor, cocoa butter, soya lecithin (added as an emulsifier)], vanilla extract, dry roasted almonds, turbinado sugar, sea salt. Allergen info: contains: soy, tree nuts (almonds). This product is packaged on shared equipment with dairy (milk) products, peanuts, soy, tree nuts and wheat. Distributed by: Bristol Farms, Carson, CA 90745 .
Cargill Sea Salt Tablets; Net Wt. 50 lbs. (22.7 kg) cardboard case. 40 grain salt tablets; Ingredients: Salt Cargill Incorporated Minneapolis, MN 55440
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
waterfront Bistro Tatar Sauce, Net Wt 9 oz. (255g), UPC 21130-12242
Wawa Fruit & Cheese, 6oz. (170g), 1 each, rigid plastic, clamshell container, sold per unit, shelf-life= 5 days.
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
Birds Eye Baby Sweet Peas, Net Wt. 13 oz. (369g ), Keep Frozen. UPC 14500-02253.
Allen's Blueberries IQF Wild Blueberries, 30 lbs. corrugated box
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Red Blood Cells, Leukocytes Reduced, Irradiated

Product Quantity
7793 cases (9 cartons per case and 6 bowls per cartons)

Reason for Recall
There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument.
The device may exhibit premature battery depletion.
Natural Selections Frozen Duck Meals for Cats product is recalled due to a potential contamination with Salmonella.
During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.
A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.
Fuji apples are recalled because Thiabendazole was detected at 6.9 ppm.
Milk Chocolate Tasty Treats nonpareils have undeclared milk as the ingredient statement on the package is incorrect.
Equipment malfunction resulted in the inclusion of very small metallic fragments and particulate matter in some lots of salt tablets.
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Silver Spring is recalling Waterfront Bistro Tartar Sauce because an incorrect back label does not identify egg.
The firm was notified that an ingredient used to manufacture the recalled product may contain wood slivers.
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Royal Asia brand Shrimp Wonton Noodle Soup is recalled due to undeclared egg.
Product has the potential to be contaminated with Listeria monocytogenes.
Product tested positive for Listeria monocytogenes
Blood product, collected from a donor who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, was distributed.
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Blood products, stored in conditions that lacked assurance of proper temperature monitoring, were distributed.
Pooled platelet products, not meeting product specifications, were distributed.

Code Info
material code 100045900; Batch numbers: 10215ADBAA, 10915ADBAA.
Best By date of JUL 31 18 S3351 and AUG 28 18 S3351
Case Lot Numbers: 3905079AB1 and 3906079AB1, Retail Package Best By: JUL-06-19 and JUL-05-19