Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
This recall has been terminated (originally issued November 19, 2016).
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- September 23, 2016
- Posted
- November 19, 2016
- Terminated
- March 27, 2017
- Recall Number
- Z-0635-2017
- Quantity
- 53 units
- Firm Location
- Jordan, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Distribution
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Lot / Code Info
Lot Numbers: H992344 and H996476
Root Cause
Process control
Action Taken
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.
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