Z-1350-2025 Class II Ongoing
FDA device recall Z-1350-2025 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: 690 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
- 690 kits
Product Description
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
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 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662