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-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: 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.