American Contract Systems recalls ENT, COEN27N medical convenience kits due to humidity readings out of spec, risking unconfirmed sterilization. Affected units have specific lot/expiry details.
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 ENT, COEN27N medical convenience kits because humidity readings in one controlled environment area were out of specification. This means they can't confirm the kits meet sterilization requirements, which is critical for medical use.
The kits have a chart recorder that doesn't work properly, causing humidity readings to be outside acceptable limits. This makes it impossible for the manufacturer to confirm that the kits meet sterilization standards, which is essential for medical safety.
Medical facilities using the ENT, COEN27N convenience kits with lot number 2405092 and expiration date 05/09/2025 are most at risk. Patients and staff using these kits could face potential sterilization issues.
Check for the model number COEN27N and lot number 2405092 on the kit. The expiration date is May 9, 2025. This specific batch was identified in the recall.
Verify the lot number (2405092) and expiration date (05/09/2025) on the medical convenience kit.
The chart recorder in the kit is inoperable, causing humidity readings to be out of specification. This means the manufacturer can't confirm the kits meet sterilization requirements.
Check the lot number and expiration date. If it matches the recalled batch (lot 2405092, exp 05/09/2025), contact American Contract Systems for further instructions.
The recall is about sterilization assurance, not direct injury risks. The hazard is that the kits may not meet sterilization standards, which is important for medical use but not a direct safety hazard.
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-3241-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3241-2024 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.
