American Contract Systems recalls Day Surgery General Pack FHGE18T due to humidity readings out of spec, potentially affecting sterilization assurance. No remedy specified in recall notice.
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 a Day Surgery General Pack (FHGE18T) because humidity readings in one controlled area were out of specification. This could mean the product wasn't properly sterilized, which is critical for medical safety.
The chart recorder in the pack can't function properly in humid conditions, leading to inaccurate humidity readings. This means the product might not meet sterilization standards, potentially causing infections during surgery.
Medical facilities using this specific pack for day surgery procedures are likely affected. Staff handling the pack during surgery may be at risk if sterilization is compromised.
Check for the model FHGE18T on the pack. The lot number is 2405131 and expiration date is May 13, 2025. This product was sold starting in 2024.
Look for the model FHGE18T, lot number 2405131, and expiration date of May 13, 2025 on the pack.
The chart recorder in the pack can't function properly in humid conditions, leading to inaccurate humidity readings and potential failure to meet sterilization standards.
The recall notice does not specify any remedy or action for affected products.
Check for the model FHGE18T, lot number 2405131, and expiration date of May 13, 2025 on the pack.
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-3231-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3231-2024 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.
