FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
- Recall number
- Z-0521-2010
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents.
- Status
- Terminated
- Initiated
- 2009-09-29
- Posted
- 2009-12-14
- Terminated
- 2009-12-15
- Reason
- Potential sterility breach caused by excessive shipment damage.
- Root cause
- Other
- Action
- Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
- Quantity
- 5 fixation devices
- Distribution
- US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
- Lot, serial or model codes
- Lot #9H4824
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KGZ
- 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