Recall Z-0629-2007 ยท KMK Device, Intravascular Catheter Securement
Merit Medical Systems, Inc
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
| Date | Mar 15, 2007 (initiated Feb 15, 2007) |
| Status | Terminated |
| Reason | Sterility of some units may be compromised due to damaged packaging. |
| Root cause | Other |
| Action | Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit. |
| Quantity | 4223 units |
| Distribution | Worldwide, including USA, France, Germany, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.