Recall Z-0215-2009 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110. The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium hep
| Date | Nov 7, 2008 (initiated Jul 29, 2008) |
| Status | Terminated |
| Reason | Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The "Product Disposition Form" must be completed by the consignee and returned to Greiner Bio-One North America, Inc. For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800. |
| Quantity | 33 cases (39,600 pieces) |
| Distribution | Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada. |
| 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 |