American Contract Systems recalls Vasc. Open CVOR SJH devices with specific lot numbers due to potential reduced drug efficacy from improper sterilization. Affected units may not function correctly or have higher chemical residues.
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 Vasc. Open CVOR SJH devices with specific lot numbers because improper sterilization could cause the devices to malfunction or reduce drug effectiveness. This affects medical use where precise functionality is critical.
The devices were exposed to higher temperatures and ethylene oxide (EO) gas during sterilization than approved by the manufacturer. This could lead to loss of functionality, reduced drug efficacy, or higher levels of EO residues.
Healthcare professionals using the Vasc. Open CVOR SJH devices with lot numbers 940231 or 974231 are most at risk. Patients receiving treatments through these devices may experience reduced effectiveness of medications.
Check the lot number on the device label: 940231 or 974231. The product is identified as Vasc. Open CVOR SJH with reference number SJVO56B.
Look for lot numbers 940231 or 974231 on the device label.
The devices were exposed to higher temperatures and ethylene oxide gas during sterilization than approved, which could cause reduced drug efficacy or malfunction.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
The recall indicates potential reduced drug efficacy, but the record does not mention patient injuries or specific safety risks.
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-0177-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0177-2024 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.
