Robotics Pack SAH, REF SAR530M
FDA Recall #Z-0174-2024 — Class II — September 1, 2023
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.
Recalling Firm
American Contract Systems, Inc. — Temple Terrace, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
96 cases
Distribution
US Nationwide distribution in the states of FL, IA.
Code Information
UDI/DI00191072179678, Lot Numbers: 949231, 983231
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.