Recall Z-0502-2022 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
| Date | Dec 9, 2021 |
| Status | Terminated |
| Reason | Some of the blood collection tubes show clotting due to variation of Lithium Heparin. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm initiated issuance of recall letters dated 12/9/2021 on the same date via email, phone, USPS, or UPS to their end-user customers. The letter explains the issue, the potential health hazard, and the necessary actions to be taken. The actions included to discontinue use of the affected product and isolate the products in their facility; assess risks and consequences for the use of the defective product in accordance with the consignee's procedures and take the appropriate action; and complete the attached Product Disposition Site Confirmation form and FAX it to the recalling |
| Quantity | 889,200 pcs. |
| Distribution | Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960857 | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR Greiner America, Inc., Aug 30, 1996 |