CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
This recall has been terminated (originally issued June 24, 2006).
- Company
- St Jude Medical Crmd
- Recall Initiated
- June 1, 2006
- Posted
- June 24, 2006
- Terminated
- March 26, 2012
- Recall Number
- Z-1167-06
- Quantity
- 4958
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
Lot / Code Info
All lots with a manufacturing date of May 30, 2006 or earlier
Root Cause
Other
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.