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Terminated

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

FDA Recall Z-0628-2007 · Posted 2007-03-15

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeKMK
Date Initiated2007-02-15
Date Terminated2011-11-09
Product Quantity51,584 units

Reason for Recall

Sterility of some units may be compromised due to damaged packaging.

Firm Action

Consignees were notified by letter on 02/23/2007. They were instructed to stop use of and return all affected product to Merit.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, France, Germany, and United Kingdom.

Official Source

View FDA Recall →

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

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