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Class 2 Device Recall Bard Platinum Class II Flat Wire Stone Basket |
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Date Initiated by Firm |
December 22, 2003 |
Date Posted |
January 09, 2004 |
Recall Status1 |
Terminated 3 on September 01, 2004 |
Recall Number |
Z-0315-04 |
Recall Event ID |
28010 |
Product Classification |
Dislodger, Stone, Basket, Ureteral, Metal - Product Code FFL
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Product |
Bard¿ 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. |
Recalling Firm/ Manufacturer |
C.R. Bard, Inc., Urological Division 8195 Industrial Blvd Ne Covington GA 30014-1497
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For Additional Information Contact |
Frances E. Harrison 770-784-6257
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Manufacturer Reason for Recall |
Product packaging may contain holes compromising sterility.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified letter on 12/22/2003. |
Quantity in Commerce |
12,684 units (total includes both types) |
Distribution |
Product was distributed Nationwide, Canada, Belgium and Japan |
Total Product Life Cycle |
TPLC Device Report
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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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