AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in
FDA device recall Z-0414-2007 · posted 2007-02-08 · Terminated
Recall details
- Recalling firm
- Ascent Healthcare Solutions, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- NLM
- Quantity affected
- 1566
- Distribution
- Nationwide
- Date initiated
- 2006-10-19
- Date posted
- 2007-02-08
- Date terminated
- 2008-10-31
- Location
- Lakeland, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (K043594) | Vanguard Medical Concepts, Inc. | 2005-03-31 |