FDA Recall
Terminated
Bard Stinger S Ablation Catheter: Item Numbers 210001S 218501S 6210015S 210002S 218502S 6210016S 210003S 218503S 6210017S 210004S 218504S 6210018S 210005S 218505S 6210019S 210006S 218506S 6210020S 210007S 218507S 210015S 218516S 210016S 218518S 210017S 218519S 210018S 218520S 210019S 218521S 210020S 218523S 210023S 218524S 210024S 218525S 210025S 218526S 210026S 218527S 210027S 218528S 210028S 218529S 210029S 210030S
Recall: Z-0600-03
·
Initiated January 8, 2003
Recall
- Recall Number
- Z-0600-03
- 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 S Ablation Catheter: Item Numbers 210001S 218501S 6210015S 210002S 218502S 6210016S 210003S 218503S 6210017S 210004S 218504S 6210018S 210005S 218505S 6210019S 210006S 218506S 6210020S 210007S 218507S 210015S 218516S 210016S 218518S 210017S 218519S 210018S 218520S 210019S 218521S 210020S 218523S 210023S 218524S 210024S 218525S 210025S 218526S 210026S 218527S 210027S 218528S 210028S 218529S 210029S 210030S
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