American Contract Systems recalls Open Shoulder LWOS39L medical kits due to humidity readings out of spec, risking unconfirmed sterilization. Affected units have specific lot numbers and expiration dates.
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 their Open Shoulder LWOS39L medical convenience kits because humidity readings were out of specification in one controlled environment area. This means they can't confirm the kits meet sterilization requirements, which is critical for medical use.
The kits have an inoperable chart recorder that causes humidity readings to be out of specification in controlled environments. This prevents ACS from confirming that the kits meet sterilization requirements, which is essential for medical safety.
Medical facilities using the Open Shoulder LWOS39L kits with lot number 2405141 and expiration date 05/14/2025 are most at risk. Patients and staff using these kits could face potential sterilization issues.
Check for the lot number 2405141 and expiration date 05/14/2025 on the kit's packaging. The product is identified as Open Shoulder LWOS39L medical convenience kit.
Verify the lot number 2405141 and expiration date 05/14/2025 on the kit's packaging.
Due to an inoperable chart recorder causing humidity readings to be out of specification in one controlled environment area, which prevents confirmation of sterilization requirements.
The recall record does not mention any remedy or fix for this issue.
The recall record does not specify any action steps beyond checking the lot number and expiration date.
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-3230-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3230-2024 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.
