American Contract Systems recalls medical procedure kits with unverified sterilization. Some components may not be safe for reuse after sterilization. Affected kits include BORN ON ARRIVAL KIT (LLBN11C) and LABOR & DELIVERY PACK (LLLD19I).
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling two types of medical procedure kits because some components may not be properly sterilized. This could mean the kits are unsafe for reuse in medical procedures. The recall affects specific kits with model numbers LLBN11C and LLLD19I.
The manufacturer found that some components in these kits were not properly sterilized as per their procedures. This means the kits might not be safe for reuse in medical procedures, potentially leading to infection risks.
Healthcare professionals using these medical kits are most at risk. The recall applies to specific kits sold with model numbers LLBN11C and LLLD19I.
Check for kits labeled 'BORN ON ARRIVAL KIT' (model LLBN11C) or 'LABOR & DELIVERY PACK' (model LLLD19I). Look for lot numbers 70-051710, 70-052354 for LLBN11C and 70-051324, 70-051967, 70-053006, 70-053303, 70-053710 for LLLD19I.
Look for model numbers LLBN11C or LLLD19I on the kit labels.
Confirm the lot numbers match those listed in the recall (70-051710, 70-052354 for LLBN11C; 70-051324, 70-051967, 70-053006, 70-053303, 70-053710 for LLLD19I).
American Contract Systems determined that some components in these kits were not properly sterilized as per their procedures, so they cannot confirm the kits meet sterilization safety requirements.
The recall record does not specify a remedy, so you should check the kit labels and lot numbers to see if it is affected. If it is, contact American Contract Systems for further instructions.
The manufacturer states that some components may not be safe for reuse after sterilization, so they are not guaranteed to be safe for medical procedures.
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-2469-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2469-2025 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.
