FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.
- Recall number
- Z-0627-2007
- Recalling firm
- Merit Medical Systems, Inc
- Product
- StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, 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
- 195,001 units
- Distribution
- Worldwide, including USA, France, Germany, and United Kingdom.
- Lot, serial or model codes
- Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104, 553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504, 554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656, 555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843, 556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518, 562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901, 566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835.
- 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