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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-0601-03
Recall Event ID 25401
Product 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
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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