Z-1714-2020 Class II Terminated
FDA device recall Z-1714-2020 was initiated by Greiner Bio-One North America, Inc. on March 12, 2020 and is designated Class II. Reason for recall: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. The recall status is terminated (terminated August 31, 2022). Affected quantity: 1,000,800 units..
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2020
- Initiation Date
- March 12, 2020
- Termination Date
- August 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,000,800 units.
Product Description
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Reason for Recall
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
Distribution Pattern
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.
Code Information
Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.