American Contract Systems recalls knee arthroscopy procedure kits with catalog number SLAR14G due to excessive ethylene oxide/ethylene chlorohydrin residuals, potentially causing tissue damage with prolonged contact.
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
American Contract Systems is recalling knee arthroscopy procedure kits with catalog number SLAR14G because ethylene oxide and ethylene chlorohy:14G. This could cause tissue damage if the cast padding is in contact with skin for extended periods.
The cast padding component in the kit contains excessive ethylene oxide and ethylene chlorohydrin residues. These chemicals can cause tissue damage if they remain in contact with skin for extended periods during medical procedures.
Healthcare professionals using the knee arthroscopy procedure kit with catalog number SLAR14G are most at risk. Patients using the kit for surgical procedures may also be affected.
Check for the catalog number SLAR14G on the kit. The lot numbers 975241 and 920241 are also associated with this recall.
Look for the catalog number SLAR14G and lot numbers 975241 or 920241 on the kit.
The cast padding component contains excessive ethylene oxide and ethylene chlorohydrin residues, which could cause tissue damage with prolonged skin contact.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected kit.
The recall record does not mention patient risks, but healthcare professionals using the kit are at risk due to potential tissue damage from chemical residues.
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-2301-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2301-2024 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.