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Merit Medical Systems, Inc. recalls COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Recalled May 17, 2023 · FDA recall Z-1578-2023 · Merit Medical Systems
Hazard
Custom sheath Introducer contains incorrect needle size · FDA Class II
Units
1186 units
Sold at
US Distribution to state of: Minnesota
Description
Custom sheath Introducer contains incorrect needle size
Product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →