Recall Z-0635-2017 ยท OJV Single Use Instrument Tray
Merit Medical Systems, Inc.
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
| Date | Nov 19, 2016 (initiated Sep 23, 2016) |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier. |
| Root cause | Process control |
| 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. |
| Quantity | 53 units |
| Distribution | Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.