Z-0732-03

Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric...

Name: Z-0732-03 Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric...
Creator: C.R. Bard, Inc., Urological Division
Published: 2003-03-25
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2003-03-25 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc., Urological Division began a recall of 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... on 2003-03-25. The reason FDA records is "There is a potential for package seals to be open after sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0732-03
Status: Terminated
Initiated: 2003-03-25
Posted: 2003-04-17
Terminated: 2003-08-07
Recalling firm: C.R. Bard Inc
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.
Product code: FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Reason for recall: There is a potential for package seals to be open after sterilization.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.

Product code FAQ

K780032Class IUrinary Leg BagC.R. Bard, Inc. / cleared 1978-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)