American Contract Systems recalls Pediatric Uro: Wolson Pack REF BPPU55A due to possible loss of function or drug efficacy from improper sterilization. Affected units have specific lot numbers.
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 Pediatric Urology Wolson Packs with model REF BPPU55A because parts were sterilized incorrectly, which might cause the product to stop working or lose drug effectiveness. This could affect medical treatments for children.
The product parts were exposed to higher temperatures and ethylene oxide gas during sterilization than approved by the manufacturer. This could cause the parts to stop working or lose the effectiveness of medications they deliver.
Healthcare providers using the Pediatric Urology Wolson Pack REF BPPU55A for children's medical treatments are most at risk. Patients receiving the product could be affected if the parts fail.
Check for the model number REF BPPU55A on the product. Affected units have lot numbers 923231 or 977231.
Look for the model number REF BPPU55A and lot numbers 923231 or 977231 on the product.
The parts were sterilized incorrectly, which might cause the product to stop working or lose drug effectiveness.
Check the model number and lot numbers to see if it's affected. If it is, contact the manufacturer for guidance.
The recall is for potential loss of function or drug efficacy, not a 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-0181-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0181-2024 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.
