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Terminated

University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

FDA Recall Z-0744-2010 · Posted 2010-01-29

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeOEZ
Date Initiated2009-01-29
Date Terminated2011-06-16
Product Quantity368 units

Reason for Recall

A manufacturing defect may prevent adequate sterilization of the entire device.

Firm Action

Applicable Merit sales representatives and distributors were notified by phone and letter beginning January 29, 2009 and instructed to immediately contact all affected consignees. Consignees were to immediately quarantine any remaining product and arrange for return to the firm. For further information, contact Merit Medical Systems, Inc. at 1-800-356-3748 extensions 4929 or 4998.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States ( PA and TX) and Japan.

Official Source

View FDA Recall →

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

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