American Contract Systems recalls BORN ON ARRIVAL Kit (Model LLBN11B) due to unconfirmed sterilization. This may cause treatment delays or reduced functionality. Affected units sold with specific lot numbers.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling a BORN ON ARRIVAL Kit (Model LLBN11B) because they can't confirm it was properly sterilized. This could lead to treatment delays or the kit not working correctly.
The kit may not be properly sterilized, which could cause treatment delays or reduced functionality. This is not a direct safety hazard like a fire or injury.
Users of the BORN ON ARRIVAL Kit for medical treatments. Patients receiving procedures that require this kit are most at risk.
Check for the model number LLBN11B on the kit. Units sold with lot numbers 891241, 70-051710, or 7:052354 are affected.
Look for the model number LLBN11B on the kit to confirm it is affected.
American Contract Systems cannot confirm the kit was properly sterilized, which may cause treatment delays or reduced functionality.
Check the model number and lot numbers to see if it is affected. If it is, contact American Contract Systems for guidance.
The recall states possible treatment delays or reduced functionality, not a direct injury risk.
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-1341-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1341-2025 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.
