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U.S. Department of Health and Human Services

Class 2 Device Recall Bard DispozABag

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  Class 2 Device Recall Bard DispozABag see related information
Date Initiated by Firm March 25, 2003
Date Posted April 17, 2003
Recall Status1 Terminated 3 on August 07, 2003
Recall Number Z-0732-03
Recall Event ID 25894
510(K)Number K780032  
Product Classification Bag, Urine Collection, Leg, For External Use, Sterile - Product Code FAQ
Product Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.
Code Information Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc., Urological Division
8195 Industrial Blvd NE
Covington GA 30014
For Additional Information Contact Frances E. Harrison
770-784-6257
Manufacturer Reason
for Recall		 There is a potential for package seals to be open after sterilization.
FDA Determined
Cause 2		 Other
Action The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.
Quantity in Commerce 283, 277 units
Distribution Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = FAQ and Original Applicant = C.R. BARD, INC.
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