FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
- Recall number
- Z-0629-2007
- Recalling firm
- Merit Medical Systems, Inc
- Product
- EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.
- Status
- Terminated
- Initiated
- 2007-02-15
- Posted
- 2007-03-15
- Terminated
- 2011-11-09
- 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.
- Lot, serial or model codes
- Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KMK
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28