Z-2507-2021 Class II Terminated
FDA device recall Z-2507-2021 was initiated by Greiner Bio-One North America, Inc. on August 20, 2021 and is designated Class II. Reason for recall: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. The recall status is terminated (terminated October 4, 2023). Affected quantity: 956,400.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 20, 2021
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 956,400
Product Description
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Reason for Recall
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.
Code Information
Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.