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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-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
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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