Recall Z-1148-06 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
United States Surgical
Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021
| Date | Jun 17, 2006 (initiated May 22, 2006) |
| Status | Terminated |
| Reason | The 9F device may contain a 10 F sheath instead of the 9F |
| Root cause | Other |
| Action | United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers. |
| Quantity | 63 UNITS |
| Distribution | Nationwide and International Australia, Brazil, Panama City, Singapore, Chile, France, Germany, Israel, Argentina, Quebec |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902135 | PERCUTANEOUS INTRODUCER KIT Device Labs, Inc., Aug 1, 1990 |