Z-1344-2025 Class II Ongoing
FDA device recall Z-1344-2025 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: 1836 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
- 1836 kits
Product Description
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-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 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-052911