Recalled American Contract Systems Gyn Laparoscopy convenience kits may have compromised sterility due to insufficient aeration time during sterilization. Affected kits include specific model numbers and expiration dates.
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
American Contract Systems is recalling certain gyn laparoscopy convenience kits because they may not have been properly sterilized due to insufficient aeration time. This could lead to infection risks if the kits are used without proper sterility.
The kits may have been compromised in sterility because they were sterilized with insufficient aeration time. This could allow contaminants to remain, increasing infection risk during surgical procedures.
Healthcare professionals using these kits for surgical procedures are most at risk. The recall affects specific model numbers and expiration dates listed in the notice.
Check for model numbers SLGL64K (UDI-DI 00191072202017, Lot 981241, Exp. 1/19/2025) or SMGY46A (UDI-DI 00191072188458, Lot 982241, Exp. 1/18/2025).
Identify the model number and expiration date on the kit to determine if it is affected.
The kits may have been compromised in sterility due to insufficient aeration time during sterilization, which could lead to infection risks.
Model SLGL64K (UDI-DI 00191072202017, Lot 981241, Exp. 1/19/2025) and Model SMGY46A (UDI-DI 00191072188458, Lot 982241, Exp. 1/18/2025).
Check the model number and expiration date on the kit. Affected kits have specific model numbers and expiration dates listed in the recall notice.
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-2518-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2518-2024 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.
