Recall Z-0002-2017
Merit Medical Systems, Inc. · initiated August 25, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Codes / lots: Lot Numbers: H959038, H970334, H984351.
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.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-0002-2017
- Initiated
- August 25, 2016
- Terminated
- December 1, 2016
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 1,297 total units
- Distribution
- One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT