Recall Z-1067-03 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Deltec, Inc
Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen External Catheter Segment, Reorder Number 21-0106
| Date | Jul 30, 2003 (initiated Jul 8, 2003) |
| Status | Terminated |
| Reason | Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state. |
| Root cause | Other |
| Action | A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive. |
| Distribution | The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904334 | PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT Pharmacia Deltec, Inc., Nov 5, 1990 |