FDA recall Z-1578-2023
Merit Medical Systems, Inc. · Class II · device
Product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Reason for recall
Custom sheath Introducer contains incorrect needle size
Distribution
US Distribution to state of: Minnesota
Key facts
- Status
- Ongoing
- Initiation date
- 2023-03-21
- Report date
- 2023-05-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- South Jordan, UT, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1578-2023