American Contract Systems recalls knee arthroscopy procedure kits with catalog number SFAR60A due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage with prolonged use.
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 (catalog number SFAR60A) because ethylene oxide and ethylene chlorohy:drin residues in the cast padding exceed safety limits. This could cause tissue damage if the kit is used for extended periods.
The cast padding in the knee arthroscopy procedure kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term exposure. This could lead to tissue damage if the kit is used for extended periods during medical procedures.
Medical professionals using the knee arthroscopy procedure kits with catalog number SFAR60A are likely affected. Patients receiving these kits during surgery may be at risk if the residues cause tissue damage.
Check for the catalog number SFAR60A on the knee arthroscopy procedure kit. The lot numbers 992241 and 954241 are also associated with this recall.
Verify the catalog number and lot numbers on the kit to confirm if it is affected.
The recall indicates ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe levels for long-term use, which could cause tissue damage. However, the risk is considered low for typical medical use.
Look for the catalog number SFAR60A and lot numbers 992241 or 954241 on the knee arthroscopy procedure kit.
The recall does not specify a remedy, so check with the manufacturer for further instructions if you have the affected kit.
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-2298-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2298-2024 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.
