Z-0628-2007

StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical...

Name: Z-0628-2007 StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical...
Creator: Merit Medical Systems, Inc
Published: 2007-02-15
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2007-02-15 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc began a recall of StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain on 2007-02-15. The reason FDA records is "Sterility of some units may be compromised due to damaged packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0628-2007
Status: Terminated
Initiated: 2007-02-15
Posted: 2007-03-15
Terminated: 2011-11-09
Recalling firm: Merit Medical Systems, Inc.
Product: StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.
Product code: KMK Device, Intravascular Catheter Securement
Reason for recall: Sterility of some units may be compromised due to damaged packaging.
Root cause tag: packaging
FDA 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 in commerce: 51,584 units
Distribution: Worldwide, including USA, France, Germany, and United Kingdom.
Product codes and lots: 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.

Product code KMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)