American Contract Systems recalls KNEE SCOPE Procedure tray (Catalog COKN48L) 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 SCOPE Procedure trays with catalog number COKN48L because residual chemicals from the manufacturing process may cause tissue damage if used for extended periods. This recall affects medical professionals who use these trays for casting procedures.
The cast padding component in these trays contains ethylene oxide and ethylene chlorohydrin residuals that exceed safe limits for long-term medical use. This could potentially cause tissue damage if the trays are used for extended periods without proper cleaning.
Medical professionals who use KNEE SCOPE Procedure trays for casting procedures are most at risk. The recall applies to specific catalog numbers and lot numbers produced by American Contract Systems.
Check for catalog number COKN48L on the tray. The affected lot numbers are 644231, 955241, and 91524: 915241. These trays were sold with UDI-DI: 00191072176301.
Look for catalog number COKN48L on the KNEE SCOPE Procedure tray.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residuals that exceed safe limits for long-term medical use, potentially causing tissue damage with prolonged use.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the catalog and lot numbers listed.
Lot numbers 644231, 955241, and 915241 are affected.
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-2287-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2287-2024 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.
