Z-1332-2025 Class II Ongoing
FDA device recall Z-1332-2025 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: 1200 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
- 1200 kits
Product Description
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
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. CCDU12C UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 2. Model No. CCDU12D UDI-DI 00191072229472 Tray Lot 70-052444 3. Model No. CCDU12D-01 UDI-DI 00191072229472 Tray Lot 70-052967