Recall Z-0859-03 ยท FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Medegen Medical Products, LLC
GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
| Date | May 22, 2003 (initiated Apr 30, 2003) |
| Status | Terminated |
| Reason | Finished products were not sterilized. |
| Root cause | Other |
| Action | Medegen has notified all direct accounts by certified mail on 4/30/03. |
| Distribution | Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.