American Contract Systems recalls CVS PCSU SJH models with specific lot numbers due to potential component failure from improper sterilization. Affected units may have reduced functionality or 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 CVS PCSU SJH devices with specific lot numbers because components were exposed to incorrect sterilization temperatures and chemicals. This could lead to reduced device functionality or loss of medication effectiveness.
The components were exposed to higher temperatures and ethylene oxide (EO) gas during sterilization than approved by the manufacturer. This could cause the components to lose functionality or reduce the effectiveness of medications.
Users of CVS PCSU SJH devices with lot numbers 945231, 954231, or 974231 are affected. Healthcare providers using these devices for medical procedures are most at risk.
Check the lot number on your CVS PCSU SJH device, which should be 945231, 954231, or 974231. The product is sold under the brand American Contract Systems.
Look for the lot number on your CVS PCSU SJH device; affected units have lot numbers 945231, 954231, or 974231.
The components were exposed to higher temperatures and ethylene oxide gas during sterilization than approved by the manufacturer, which could cause reduced functionality or loss of medication effectiveness.
Check the lot number on your device; if it is 945231, 954231, or 974231, contact American Contract Systems for further instructions.
The recall does not mention a risk of serious injury; the hazard is limited to potential component failure and reduced medication effectiveness.
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-0175-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0175-2024 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.
