CPS Valve Bypass Tool (VBT), Model 410192
FDA device recall Z-1165-06 · posted 2006-06-24 · Terminated
Recall details
- Recalling firm
- St Jude Medical CRMD
- Reason for recall
- Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Action taken
- The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 775
- Distribution
- Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
- Date initiated
- 2006-06-01
- Date posted
- 2006-06-24
- Date terminated
- 2012-03-26
- Location
- Sylmar, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 (K053217) | St Jude Medical | 2006-03-08 |