Recall Z-0314-04 ยท FFL Dislodger, Stone, Basket, Ureteral, Metal
C.R. Bard, Inc., Urological Division
Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
| Date | Jan 9, 2004 (initiated Dec 22, 2003) |
| Status | Terminated |
| Reason | Product packaging may contain holes compromising sterility. |
| Root cause | Other |
| Action | Consignees were notified by certified letter on 12/22/2003. |
| Quantity | 12,684 units (total includes both types) |
| Distribution | Product was distributed Nationwide, Canada, Belgium and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.