Z-1359-2025 Class II Ongoing
FDA device recall Z-1359-2025 was initiated by American Contract Systems Inc on February 6, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 54 kits.
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
- 54 kits
Product Description
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-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 00191072184450 00191072221070 Lots 921241 70-051173 70-052439