American Contract Systems recalls Robotics Pack SAH REF SAR530M due to potential component failure from improper sterilization. Affected units may have reduced functionality or drug efficacy issues.
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.
American Contract Systems is recalling Robotics Pack SAH REF SAR53:0M because sterilization errors could cause components to malfunction or lose drug effectiveness. This affects medical devices used in healthcare settings.
The components were exposed to higher temperatures and EO gas during sterilization than approved. This could lead to reduced functionality or loss of drug effectiveness in medical applications.
Healthcare professionals using the Robotics Pack SAH REF SAR530M are most at risk. The recall applies to specific lot numbers produced for medical use.
Check for the model number SAR530M and lot numbers 949231 or 983231 on the device. The product is used in medical settings.
Identify the model number SAR530M and lot numbers 949231 or 983231 to confirm if your device is affected.
The components were exposed to higher temperatures and EO gas during sterilization than approved, which could cause reduced functionality or loss of drug effectiveness.
The recall record does not specify a remedy, so no action is required beyond checking if your device matches the affected model and lot numbers.
The recall indicates potential reduced functionality or loss of drug effectiveness, but no immediate safety risks like injury or death are mentioned.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0174-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0174-2024 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
