Recall Z-1166-06 ยท DQY Catheter, Percutaneous
St Jude Medical CRMD
CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
| Date | Jun 24, 2006 (initiated Jun 1, 2006) |
| Status | Terminated |
| Reason | Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process. |
| Root cause | Other |
| Action | 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. |
| Quantity | 6290 |
| Distribution | Hospitals/Medical Centers in AZ, CA, MS, NY, & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053217 | CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 St Jude Medical, Mar 8, 2006 |