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Terminated

Merit Medical systems, Inc, Convenience Kit REF/CAT no.: K09-07692 REVISION A , CUSTOM KIT

FDA Recall Z-0524-2010 · Posted 2009-12-14

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2009-09-29
Date Terminated2009-12-15
Product Quantity30 kits

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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