Z-1358-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 kits
Product Description
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Distribution Pattern
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158