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-0599-03
• Recall Event ID: 25401
• Product: Bard Stinger M Ablation Catheters: Item Numbers 210001M 218501M 210002M 218502M 210003M 218503M 210004M 218504M 210005M 218505M 210006M 218506M 210007M 218507M 210015M 218516M 210016M 218518M 210017M 218519M 210018M 218520M 210019M 218521M 210020M 218523M 210023M 218524M 210024M 218525M 210025M 218526M 210026M 218527M 210027M 218528M 210028M 218529M 210029M 210030M
• Code Information: All lot numbers were the 4th digit contains the letter A through M. Ex. 07A''A''1234
• FEI Number: 1000120754
• 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.