—#150164

Product

Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A

FDA product code: OJV — Single Use Instrument Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: H992344 and H996476

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

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

Timeline

Recall initiated: 2016-09-23
Posted by FDA: 2016-11-19
Terminated: 2017-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150164. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.