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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Platinum Class II Flat Wire Stone Basket

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 Class 2 Device Recall Bard Platinum Class II Flat Wire Stone Basketsee related information
Date Initiated by FirmDecember 22, 2003
Date PostedJanuary 09, 2004
Recall Status1 Terminated 3 on September 01, 2004
Recall NumberZ-0315-04
Recall Event ID 28010
Product Classification Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
ProductBard Platinum Class II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Code Information Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information ContactFrances E. Harrison
770-784-6257
Manufacturer Reason
for Recall		Product packaging may contain holes compromising sterility.
FDA Determined
Cause 2		Other
ActionConsignees were notified by certified letter on 12/22/2003.
Quantity in Commerce12,684 units (total includes both types)
DistributionProduct was distributed Nationwide, Canada, Belgium and Japan
Total Product Life CycleTPLC Device Report
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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