Class 2 Device Recall

• Date Initiated by Firm: January 08, 2003
• Date Posted: February 28, 2003
• Recall Status: Terminated 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: 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.