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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-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 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.
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.
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