Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 2770
FDA device recall Z-0078-2013 · posted 2012-10-18 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
- Action taken
- Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical. We sincerely apologize for any inconvenience this action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 126 units
- Distribution
- Nationwide Distribution including the state of Nevada.
- Date initiated
- 2012-09-25
- Date posted
- 2012-10-18
- Date terminated
- 2012-11-08
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240 (K993157) | Weck Closure Systems | 1999-12-17 |