American Contract Systems recalls Pediatric Heart SJH REF SJPH34K due to potential component failure from improper sterilization. Affected units may have loss of function or reduced 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 Pediatric Heart SJH REF SJPH34K devices because sterilization issues could cause components to malfunction or lose drug effectiveness. This affects medical devices used in pediatric heart treatments.
The sterilization process exposed components to higher temperatures and EO gas than approved, which may cause loss of function or reduced drug effectiveness. This could impact treatment outcomes for pediatric patients.
Pediatric patients receiving heart treatments with the affected devices. Healthcare providers using the specific model are most at risk.
Check for the model number REF SJPH34K on the device. Affected units have UDI/DI 00191072167064 and lot numbers 975231.
Identify the model number REF SJPH34K and UDI/DI 00191072167064 on the device.
The components were exposed to higher temperatures and EO gas during sterilization, which may cause loss of function or reduced drug effectiveness.
Check the device for the model number REF SJPH34K and UDI/DI 00191072167064. If affected, contact American Contract Systems for further instructions.
The recall addresses potential component failure, but the record does not mention 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-0176-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0176-2024 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.
