Waste Management Kit. Catalog Number K10-04381AP
FDA Recall Z-0633-2017 · Posted 2016-11-19
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeOJV
Date Initiated2016-09-23
Date Terminated2017-03-27
Product Quantity30 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.