American Contract Systems recalls MAJOR KNEE Procedure tray (Catalog ASKN23B) with EO/ECH residuals exceeding safety limits. Affected units may pose health risks during long-term 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 a specific procedure tray used in medical settings because chemical residues from the manufacturing process may exceed safe levels for long-term use. This could potentially cause health issues if the tray is used for extended periods without proper cleaning.
The procedure tray contains ethylene oxide or ethylene chlorohydrin residues that exceed safety limits for long-term medical use. These chemicals can cause health issues if the tray is used without proper cleaning or if residues remain on the cast padding.
Healthcare professionals and medical facilities that use the MAJOR KNEE Procedure tray (Catalog Number ASKN23: ASKN23B) are most at risk. Patients using the tray for extended periods may also be affected.
Check for the catalog number ASKN23B on the tray. The product was sold with UDI-DI: 00191072216885 and lot numbers starting with 946241.
Inspect the tray for visible chemical residues or discoloration, though the recall is based on testing rather than visible signs.
The recall indicates that chemical residues may exceed safe levels for long-term use, so it is not recommended for continued use without proper cleaning.
Look for the catalog number ASKN23B on the tray, with UDI-DI: 00191072216885 and lot numbers starting with 946241.
The recall does not specify a remedy, so contact American Contract Systems directly for guidance on safe handling or disposal.
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-2276-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2276-2024 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.
