Recall Z-1625-2012 ยท KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
MEDDEV USA, INC.
50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.
| Date | May 17, 2012 (initiated May 10, 2012) |
| Status | Terminated |
| Reason | The device was marketed without a 510(k) and is not sterile. |
| Root cause | No Marketing Application |
| Action | MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559. |
| Quantity | 20 units |
| Distribution | Nationwide Distribution including Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.