Recall Z-0648-05 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Teleflex Medical, Inc.
Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****
| Date | Mar 23, 2005 (initiated May 13, 2004) |
| Status | Terminated |
| Reason | Firm received complaints of leaking urine collection bags. |
| Root cause | Other |
| Action | Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004. |
| Quantity | 1227 bags |
| Distribution | Nationwide, Australia, Japan and the UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.