Recall Z-0253-2007 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417
| Date | Dec 6, 2006 (initiated Sep 8, 2006) |
| Status | Terminated |
| Reason | Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification. |
| Root cause | Other |
| Action | Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed |
| Quantity | 1,744,400 |
| Distribution | Worldwide, including USA, Canada, and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991088 | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE Becton Dickinson Vacutainer Systems, May 28, 1999 |