American Contract Systems recalls LAVH and REF BBLV21C devices due to potential reduced drug efficacy from improper sterilization. Affected units have specific lot numbers and UDI/DI codes.
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 LAVH and REF BBL:21C medical devices because components were exposed to higher temperatures and EO gas during sterilization. This could lead to reduced drug effectiveness in treatments.
The components were exposed to higher temperatures and EO gas during sterilization than approved by the manufacturer. This could cause reduced drug effectiveness in treatments, but does not pose an immediate risk of injury or death.
Patients using LAVH or REF BBLV21C devices with specific lot numbers and UDI/DI codes. Healthcare providers administering these devices are most at risk.
Check for the lot number 686221 and UDI/DI code 00191072166234 on the device packaging or label. The product names are LAVH and REF BBLV21C.
Look for the lot number 686221 and UDI/DI code 00191072166234 on the device packaging or label.
The components were exposed to higher temperatures and EO gas during sterilization than approved by the manufacturer, which could lead to reduced drug effectiveness.
Check for the lot number 686221 and UDI/DI code 00191072166234 on the device packaging or label. If you have the affected product, contact American Contract Systems for further instructions.
The recall is for potential reduced drug effectiveness, not an immediate risk of injury or death.
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-0172-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0172-2024 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.
