Z-1578-2023 Class II Ongoing
FDA device recall Z-1578-2023 was initiated by Merit Medical Systems, Inc. on March 21, 2023 and is designated Class II. Reason for recall: Custom sheath Introducer contains incorrect needle size The recall status is ongoing. Affected quantity: 1186 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2023
- Initiation Date
- March 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1186 units
Product Description
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 Pattern
US Distribution to state of: Minnesota
Code Information
Lot # H2122096S1; UDI-DI: (00)884450525197