FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc., Urological Division: 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 number
- Z-0732-03
- Recalling firm
- C.R. Bard, Inc., Urological Division
- 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.
- Status
- Terminated
- Initiated
- 2003-03-25
- Posted
- 2003-04-17
- Terminated
- 2003-08-07
- Reason
- There is a potential for package seals to be open after sterilization.
- 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
- 283, 277 units
- Distribution
- Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
- Lot, serial or model codes
- Catalogue #150719, 150732, 150819, 150832, Lot numbers beginning with 76JL through 76BN.
- 510(k) numbers
- ["K780032"]
- PMA numbers
- not on file
- Product code
- FAQ
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28