Recall Z-1714-2020
Greiner Bio-One North America, Inc. · initiated March 12, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Codes / lots: Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.
Reason for recall
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
FDA-determined cause: Process change control
Action taken
Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112.
Details
- Recall number
- Z-1714-2020
- Initiated
- March 12, 2020
- Terminated
- August 31, 2022
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Quantity
- 1,000,800 units.
- Distribution
- US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.
- Recalling firm
- Greiner Bio-One North America, Inc., Monroe, NC