Recall Z-0629-2007
Merit Medical Systems, Inc · initiated February 15, 2007
Product
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
Codes / lots: Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
Reason for recall
Sterility of some units may be compromised due to damaged packaging.
FDA-determined cause: Other
Action taken
Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.
Details
- Recall number
- Z-0629-2007
- Initiated
- February 15, 2007
- Posted by FDA
- March 15, 2007
- Terminated
- November 9, 2011
- Product code
- KMK – Device, Intravascular Catheter Securement
- Quantity
- 4223 units
- Distribution
- Worldwide, including USA, France, Germany, and United Kingdom.
- Recalling firm
- Merit Medical Systems, Inc, South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0627-2007 | StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit…Sterility of some units may be compromised due to damaged packaging. | 02/15/2007Terminated |
| Z-0628-2007 | StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit…Sterility of some units may be compromised due to damaged packaging. | 02/15/2007Terminated |