Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designe
FDA device recall Z-0968-2007 · posted 2007-06-27 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Reason for recall
- Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
- Action taken
- Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.
- Root cause
- Other
- Status
- Terminated
- Product code
- FZP
- Quantity affected
- 187 (US 155, OUS 32)
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-02-08
- Date posted
- 2007-06-27
- Date terminated
- 2008-02-24
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K031623) | Coalescent Surgical | 2003-07-03 |