Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.
FDA device recall Z-0732-03 · posted 2003-04-17 · Terminated
Recall details
- Recalling firm
- C.R. Bard, Inc., Urological Division
- Reason for recall
- There is a potential for package seals to be open after sterilization.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FAQ
- Quantity affected
- 283, 277 units
- Distribution
- Product was distributed to 16 doctors, 79 hospitals, 280 distributors, and 53 sales representatives nationwide.
- Date initiated
- 2003-03-25
- Date posted
- 2003-04-17
- Date terminated
- 2003-08-07
- Location
- Covington, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| URINARY LEG BAG (K780032) | C.R. Bard, Inc. | 1978-01-17 |