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Terminated

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.

FDA Recall Z-0521-2010 · Posted 2009-12-14

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeKGZ
Date Initiated2009-09-29
Date Terminated2009-12-15
Product Quantity5 fixation devices

Reason for Recall

Potential sterility breach caused by excessive shipment damage.

Firm 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.

Root Cause

Other

Distribution Pattern

US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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