Recall Z-3028-2011 ยท KST System, Blood Collection, Vacuum-Assisted, Manual
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.
| Date | Aug 16, 2011 (initiated Apr 22, 2011) |
| Status | Terminated |
| Reason | BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub. |
| Root cause | Device Design |
| Action | BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117. |
| Quantity | 1,744,000 |
| Distribution | Nationwide (USA) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.