Recall Z-1212-06 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Vanguard Medical Concepts, Inc
Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
| Date | Jul 12, 2006 (initiated Mar 17, 2006) |
| Status | Terminated |
| Reason | Review of complaints and testing show that the distal tip of the trocars may separate while in use. |
| Root cause | Package design/selection |
| Action | The firm sent recall notification letters to its consignees on 3-17-2006. They were instructed to discontinue use of the 35NLT, 35NST and 35Ol Reprocessed Optiview Trocars with expiration date of 12/20008 or earlier immediately. Any of this product in inventory were to be returned to the manufacturer for credit. The firm also offered the assistance of its representatives in returning all affected profucts. The investigation is ongoing, and corrective actions associated with the root cause of tips breaking off have been identified and are being implemented. |
| Quantity | 13,842 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS Vanguard Medical Concepts, Inc., Apr 8, 2005 |