St Jude Medical CRMD CPS Slitter, Model 410191 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CPS Slitter, Model 410191
Brand
St Jude Medical CRMD
Lot Codes / Batch Numbers
All lots with a manufacturing date of May 30, 2006 or earlier
Products Sold
All lots with a manufacturing date of May 30, 2006 or earlier
St Jude Medical CRMD is recalling CPS Slitter, Model 410191 due to Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IN, MS, NY, PA
Page updated: Jan 10, 2026