Recall Z-0590-2008 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
| Date | Jan 23, 2008 (initiated Nov 20, 2007) |
| Status | Terminated |
| Reason | Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel. |
| Root cause | Material/Component Contamination |
| Action | BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174 |
| Quantity | 769,200 USA; 1,300 Canada |
| Distribution | Worldwide-USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET Becton, Dickinson & CO, Aug 29, 2001 |