Recall Z-2485-2021 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
| Date | Aug 13, 2021 |
| Status | Terminated |
| Reason | Blood collection tubes may experience a clotting issue. |
| Root cause | Process control |
| Action | A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter. |
| Quantity | 962,400 tubes |
| Distribution | Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 12, 1997 |