FDA-Device2016-10-12Class IIMISBRANDING
Merit Inflation Syringe Kit recalled for missing required device labeling
Check Merit Inflation Syringe Kit labels
Merit Medical Systems is recalling certain Merit Inflation Syringe Kits because the unit labels are missing required device information. This affects 1,297 units with specific lot numbers distributed to one facility in California. No injuries have been reported.
- Check if you have a Merit Inflation Syringe Kit with lot numbers H959038, H970334, or H984351
- Verify the label has all required device information before use
- Contact Merit Medical Systems or your supplier for instructions on replacement or return
Hazard
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
Sold states
One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
Affected count
1,297 total units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2017More Merit Medical Systems, Inc. recalls
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