American Contract Systems recalls Cath Cardiac Packs with specific lot numbers due to potential reduced drug efficacy from improper sterilization. Affected units may have compromised components.
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 Cath Cardiac Packs with specific lot numbers because the components were exposed to higher temperatures and EO gas during sterilization. This could lead to reduced drug effectiveness or loss of functionality in the medical device.
The components were exposed to higher temperatures and EO gas during sterilization than approved by the manufacturer. This can cause the components to lose functionality or have reduced drug effectiveness, potentially impacting medical treatment outcomes.
Healthcare professionals using the Cath Cardiac Pack for cardiac procedures are most at risk. Patients receiving treatments with these packs may experience reduced drug efficacy.
Check for lot numbers 724221, 679221, or 945231 on the Cath Cardiac Pack packaging. The product is identified by the reference number IHCC03V and UDI/DI 00191072189431.
Look for lot numbers 724221, 679221, or 945231 on the Cath Cardiac Pack packaging.
The components were exposed to higher temperatures and EO gas during sterilization than approved by the manufacturer, which may cause loss of functionality or reduced drug efficacy.
Check the lot number on the packaging. If it matches 724221, 679221, or 945231, contact American Contract Systems for further instructions.
The recall addresses potential reduced drug efficacy or loss of functionality, not a direct risk of serious injury.
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-0182-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0182-2024 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.
