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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 08, 2003
Date Posted February 28, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0600-03
Recall Event ID 25401
Product 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
Code Information All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
Recalling Firm/
Manufacturer		 C. R.Bard, Inc./Electrophysiology Division
129 Concord Road
Billerica MA 01821
For Additional Information Contact Chris O. Fappiano
978-323-2230
Manufacturer Reason
for Recall		 Sterile barrier maybe perforated compromising sterility of the device
FDA Determined
Cause 2		 Packaging process control
Action Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
Distribution Nationwide
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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