Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL
FDA device recall Z-1212-06 · posted 2006-07-12 · Terminated
Recall details
- Recalling firm
- Vanguard Medical Concepts, Inc
- Reason for recall
- Review of complaints and testing show that the distal tip of the trocars may separate while in use.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- NLM
- Quantity affected
- 13,842
- Distribution
- Nationwide.
- Date initiated
- 2006-03-17
- Date posted
- 2006-07-12
- 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 DILATING TIP AND BLUNT TROCARS (K043253) | Vanguard Medical Concepts, Inc. | 2005-04-08 |