Z-1167-06
CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
Abbott Medical / initiated 2006-06-01 / Terminated / root cause: packaging
St Jude Medical CRMD began a recall of CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 on . The reason FDA records is "Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1167-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
- Product code
- DQY Catheter, Percutaneous
- 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.
- Root cause tag
- packaging
- FDA 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 in commerce
- 4958
- Distribution
- Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
- Product codes and lots
- All lots with a manufacturing date of May 30, 2006 or earlier
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