FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.
- Recall number
- Z-0628-2007
- Recalling firm
- Merit Medical Systems, Inc
- Product
- StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, 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
- 51,584 units
- Distribution
- Worldwide, including USA, France, Germany, and United Kingdom.
- Lot, serial or model codes
- Lot Numbers: 547745, 551172, 554699, 555705, 555706, 556394, 556395, 556396, 556876, 556877, 558988, 560767, 560768, 560781, 561127, 561144, 562749, 562750, 563256, 563257, 563387, 564684, 564685, 565284, 565285, 565353, 565955, 566684, 566905, 566906, 566907, 567383, 567513, 567728, 569474.
- 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