Recall Z-1093-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
United States Surgical Corporation
ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with 9 French Introducer Kit with Silicone Catheter Catalog Number: 120025
| Date | Aug 6, 2005 (initiated Jun 30, 2005) |
| Status | Terminated |
| Reason | The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use |
| Root cause | Other |
| Action | United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product. |
| Quantity | 720 units |
| Distribution | Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902135 | PERCUTANEOUS INTRODUCER KIT Device Labs, Inc., Aug 1, 1990 |