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Terminated

Manifold Kit. Catalog Number K09-11867AP

FDA Recall Z-0632-2017 · Posted 2016-11-19

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeOJV
Date Initiated2016-09-23
Date Terminated2017-03-27
Product Quantity40 units

Reason for Recall

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Firm Action

Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.

Root Cause

Process control

Distribution Pattern

Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.

Official Source

View FDA Recall →

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

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