American Contract Systems recalls 16 medical procedure kits due to unverified sterilization of components. Products may not meet sterilization standards, posing potential infection risks. Affected kits include A-C Supplement Pack, Kidney Perfusion Pack, and others.
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 16 types of medical procedure kits and trays because some components weren't properly sterilized. This could lead to infections if the kits are used in medical procedures.
The recall states that during an internal investigation, American Contract Systems found that the rationale for sterilizing certain components wasn't justified. As a result, they can't confirm that the products meet sterilization standards, which could lead to infection risks if used improperly.
Healthcare professionals and medical facilities that use these kits for procedures. The risk is primarily for those handling the kits during surgeries or medical treatments.
Check for the model/item numbers listed: ANCV67X, ANKP15AD, FYLA38G, HSCY13M, HSDR10K, HSMD20H, PDSA12D, SWPD12K, UDAA63AH, UDBC35AF, UDBH37AX, UIFF72AD, UIPC89D, UITR45W, UMTR17B, UMTR17C. Also look for the specific lot numbers provided for each model.
Look for the model/item numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
American Contract Systems determined that the rationale for sterilizing certain components wasn't justified, so they can't confirm the products meet sterilization standards.
The recall doesn't specify a remedy, so contact American Contract Systems directly for guidance on next steps.
The recall indicates potential infection risks if the kits are used without confirmed sterilization, but no specific injury mechanism is described.
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-2467-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2467-2025 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.
