Reported May 17, 2023 · Ongoing
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- COBRA-OS, custom Sheath Introducer Kit, 4 French
- REFE01P2, Sterile EO, Single Use, RX Only, 5 Units
- Lot codes and dates
- Lot # H2122096S1
- UDI-DI(00)884450525197
- Amount recalled
- 1186 units
Where it was sold
Why it was recalled
Custom sheath Introducer contains incorrect needle size
This product could cause temporary or reversible health problems — stop using it.
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