Merit Inflation Syringe Kit. Catalog Number KOS-02857
FDA Recall Z-0002-2017 · Posted None
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeMAV
Date Initiated2016-08-25
Date Terminated2016-12-01
Product Quantity1,297 total units
Reason for Recall
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Firm Action
Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units.
The returned units will be re-labeled.
For further questions, please call (801) 316-3690.
Root Cause
Labeling design
Distribution Pattern
One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.