Z-1331-2025 Class II Ongoing
FDA device recall Z-1331-2025 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: 303 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
- 303 kits
Product Description
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
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
1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051