Device product
Fluid Management Set. Catalog Number K08-MP5159A
Z-0631-2017
Product summary
- Event
- Event 75367
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178 units
- Official record key
device-enforcement:Z-0631-2017
Official wording
Reason: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Code information: Lot Number: H996433
Distribution pattern: Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Derived failure modes
-
Sterility assurance
compromised sterile barrier