Recall Z-0586-04 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy
BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit.
| Date | Jul 20, 2004 (initiated Feb 3, 2004) |
| Status | Terminated |
| Reason | Splittable catheter introducer may not fully split or may separate non-uniformly. |
| Root cause | Other |
| Action | On 02/03/2004, all consignees were notified by telephone and letter. |
| Quantity | 1560 kits |
| Distribution | Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974764 | INTROSYTE CATHETER Becton Dickinson Infusion Therapy Systems, Inc., Feb 26, 1998 |