American Contract Systems recalls Hand Pack AKHD97C medical kits due to potential sterilization failure from humidity issues. Affected units may not meet sterilization standards.
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling Hand Pack medical kits with model AKHD97C because humidity problems could mean the kits aren't properly sterilized. This affects medical use safety.
The kits have a faulty humidity sensor that causes humidity readings to be inaccurate. This means the sterilization process might not work properly, potentially leading to unsterilized items.
Medical professionals using the Hand Pack kits with model AKHD97C are most at risk. The recall applies to specific batch numbers produced in 2024.
Check for the model number AKHD97C on the kit. Affected units were produced with lot number 2405102 and expire May 2025.
Look for the model number AKHD97C on the medical kit.
The kits have a faulty humidity sensor that may cause humidity readings to be out of specification, potentially affecting sterilization.
Check for model AKHD97C and lot number 2405102 on the kit. The kits expire May 2025.
The recall does not specify a remedy, so no action is required unless you have concerns about sterilization.
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-3237-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3237-2024 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.
