FDA-Device2023-05-17Class II
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Merit Medical Systems, Inc.
Hazard
Custom sheath Introducer contains incorrect needle size
Sold states
US Distribution to state of: Minnesota
Affected count
1186 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1578-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief