Recall Z-0414-2007 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Ascent Healthcare Solutions, Inc.
AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
| Date | Feb 8, 2007 (initiated Oct 19, 2006) |
| Status | Terminated |
| Reason | The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging. |
| Root cause | Process design |
| Action | The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form. |
| Quantity | 1566 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES Vanguard Medical Concepts, Inc., Mar 31, 2005 |