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Terminated

Merit Custom Procedure Kit

FDA Recall Z-0080-06 · Posted 2005-10-21

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2005-09-02
Date Terminated2005-10-28
Product Quantity372 units

Reason for Recall

Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.

Firm Action

Consignees were notified by letter on 9/2/2005.

Root Cause

Other

Distribution Pattern

DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K913682MERIT CUSTOM KITMerit Medical Systems, Inc. · 1991-11-15

Official Source

View FDA Recall →

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

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