Recall Z-0628-05 ยท DYB Introducer, Catheter
Becton Dickinson Infusion Therapy
BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
| Date | Mar 18, 2005 (initiated Jan 10, 2005) |
| Status | Terminated |
| Reason | Various procedure trays and kits may have an insufficient seal, thus compromising sterility. |
| Root cause | Other |
| Action | Customers were contacted by telephone and by letters dated 01/10/05. |
| Quantity | 15 units |
| Distribution | Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941428 | EXACTA PERCUTANEOUS INTRODUCER SHEATH Ohmeda Medical, Jul 6, 1994 |