Recall Z-0549-04 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
VACUTAINER Brand Push Button Blood Collection Sets.
| Date | Feb 25, 2004 (initiated Dec 17, 2003) |
| Status | Terminated |
| Reason | A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised. |
| Root cause | Other |
| Action | BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded. |
| Quantity | 4400 |
| Distribution | The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA. |
| 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 |