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American Contract Systems, Inc. Recall 93086

Description: Robotics Pack SAH, REF SAR530M

American Contract Systems, Inc. Recall 93086 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0174-2024
Event ID93086
Event DescriptionRobotics Pack SAH, REF SAR530M
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, IA.
Quantity96 cases
Recall ReasonDuring 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.
Device Classification20231101
Device Code InfoUDI/DI00191072179678, Lot Numbers: 949231, 983231
Center Classification Date20231026
Recall Initiation Date20230901
Recalling FirmAmerican Contract Systems, Inc.
Initial Notification E-Mail
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