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.
FDA Recall Z-0732-03 · Posted 2003-04-17
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Recalling FirmC.R. Bard, Inc., Urological Division
Recall StatusTerminated
Product CodeFAQ
Date Initiated2003-03-25
Date Terminated2003-08-07
Product Quantity283, 277 units
Reason for Recall
There is a potential for package seals to be open after sterilization.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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