FDA Recall
Terminated
Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM
Recall: Z-0601-03
·
Initiated January 8, 2003
Recall
- Recall Number
- Z-0601-03
- Event Number
- 25401
- Firm
- C. R.Bard, Inc./Electrophysiology Division
- FEI Number
- 1000120754
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 8, 2003
- Posted
- February 28, 2003
- Terminated
- May 3, 2012
- Address
- 129 Concord Road, Billerica, MA, 01821
Description
Bard Stinger SM Ablation Catheter Item Numbers 210001SM 218501SM 210002SM 218502SM 210003SM 218503SM 210004SM 218504SM 210005SM 218505SM 210006SM 218506SM 210007SM 218507SM 210015SM 218516SM 210016SM 218518SM 210017SM 218519SM 210018SM 218520SM 210019SM 218521SM 210020SM 218523SM 210023SM 218524SM 210024SM 218525SM 210025SM 218526SM 210026SM 218527SM 210027SM 218528SM 210028SM 218529SM 210029SM 210030SM
Reason
Sterile barrier maybe perforated compromising sterility of the device
Action
Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
Distribution
Nationwide