Z-0174-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- September 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 cases
Product Description
Robotics Pack SAH, REF SAR530M
Reason for Recall
During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
Distribution Pattern
US Nationwide distribution in the states of FL, IA.
Code Information
UDI/DI00191072179678, Lot Numbers: 949231, 983231