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-0598-03
• Recall Event ID: 25401
• PMA Number: P000020
• Product: Bard Stinger Ablation Catheter: Item Numbers 210001 218501 L210001 210002 218502 L210002 210003 218503 L210003 210004 218504 L210004 210005 218505 L210005 210006 218506 L210006 210007 218507 L210007 210015 218516 L210008 210016 218518 L210009 210017 218519 L210010 210018 218520 L210011 210019 218521 L210012 210020 218523 L210013 210023 218524 L210014 210024 218525 L210015 210025 218526 L210016 210026 218527 L210017 210027 218528 L210018 210028 218529 210029 210030
• 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.
• Quantity in Commerce: 18,706 units
• 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.