Recall Z-0732-03 ยท FAQ Bag, Urine Collection, Leg, For External Use, Sterile
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.
| Date | Apr 17, 2003 (initiated Mar 25, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780032 | URINARY LEG BAG C.R. Bard, Inc., Jan 17, 1978 |