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.
- Recall Initiated
- March 25, 2003
- Posted
- April 17, 2003
- Terminated
- August 7, 2003
- Recall Number
- Z-0732-03
- Quantity
- 283, 277 units
- Firm Location
- Covington, GA
Reason for Recall
There is a potential for package seals to be open after sterilization.
Distribution
Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
Lot / Code Info
Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
Root Cause
Other
Action Taken
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.