Merit Inflation Syringe Kit recall: Labeling Error
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Why was Merit Inflation Syringe Kit recalled?
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: H959038, H970334, H984351.
- Product
- Merit Inflation Syringe Kit. Catalog Number KOS-02857
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1,297 total units
- Distribution
- One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
- Recall date
- October 12, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)