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Terminated

Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

FDA Recall Z-1700-2008 · Posted 2008-09-04

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2008-04-15
Date Terminated2008-09-03
Product Quantity10 kits

Reason for Recall

Convenience kits may be non-sterile due to inadequate package sealing.

Firm Action

Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.

Root Cause

Process control

Distribution Pattern

MO. Foreign distribution to Japan. No military or government distribution.

Official Source

View FDA Recall →

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

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