American Contract Systems recalls 7 medical procedure kits due to unverified sterilization status. Some components may not meet sterilization standards, risking infection during surgery.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling seven medical procedure kits and trays because some components were not properly sterilized as per their procedures. This could lead to infections during surgical procedures if the kits are used.
The recall states that some components were not fit for further sterilization according to ACS procedures. This means the kits might not meet sterilization standards, potentially leading to infections during surgical procedures.
Healthcare professionals using these medical kits for surgeries are most at risk. Patients undergoing procedures with these kits may face infection risks.
Check for the model/item numbers: AMAH40N, CCKM67F, HSTH03N, MIAH65B, MPWH01B, SPKA57T, or WVAH40H. Look for specific lot numbers listed in the recall notice.
Identify the model/item number and lot numbers listed in the recall notice to confirm if your kit is affected.
American Contract Systems determined that some components were not fit for further sterilization according to their procedures, so they cannot confirm product sterilization assurance requirements were met.
The recall does not specify a remedy, so check the product details to see if it is affected and contact the manufacturer for further instructions.
The recall indicates a risk of infection during surgery if the kits are used, but the hazard level is low risk as the remedy does not require immediate action.
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-2472-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2472-2025 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.
