Recall Z-2134-2008 ยท FMI Needle, Hypodermic, Single Lumen
Greiner Bio-One North America, Inc.
Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the holder. It is intended for use in routine specimen withdrawal from collection bags or bottles through needless cannula ports.
| Date | Sep 11, 2008 (initiated May 16, 2008) |
| Status | Terminated |
| Reason | At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out. |
| Root cause | Device Design |
| Action | Consignees were notified by letter on/about 05/16/2008. They were instructed to stop distributing the affected lots immediately and destroy any of the product they may have. A Product Disposition form was attached to be completed and returned via fax to Greiner bio-one. Consignees instructed to notify their customers and to provide Greiner bio-one with a list of their customers that have received the item. If you have any questions contact Manfred Abel at 704-261-7823. |
| Quantity | 1,606,005 units |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980768 | VACUETTE HOLDEX Greiner Meditech, Inc., Apr 9, 1998 |