American Contract Systems recalls Robotics Pack REF SSRO22D due to potential component failure from improper sterilization. Affected units may have loss of function or reduced drug efficacy.
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 REF SSRO22D because sterilization errors may cause components to fail or lose drug effectiveness. This could affect medical use if the device is used for injections or similar procedures.
The components were exposed to excessive heat and ethylene oxide gas during sterilization. This could cause the components to stop working properly or reduce the effectiveness of drugs if used.
Medical professionals using the Robotics Pack for procedures involving injections or drug delivery are most at risk. Patients using the device for medical treatments may also be affected.
Check for the Robotics Pack model REF SSRO22D with UDI/DI 00191072167705 and lot numbers 933231 or 987231.
Verify the Robotics Pack model REF SSRO22D with UDI/DI 00191072167705 and lot numbers 933231 or 987231.
The components were exposed to excessive heat and ethylene oxide gas during sterilization, which may cause them to fail or reduce drug effectiveness.
Check the product details to see if it matches the recalled model and lot numbers. No specific action is required beyond verification.
The recall addresses potential component failure but does not mention a risk of serious injury. The hazard is limited to possible loss of function or reduced drug efficacy.
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-0179-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0179-2024 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.
