American Contract Systems recalls CUSTOM KNEE 206061 Procedure Kit (UDKN68AG) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, which may cause skin irritation or allergic reactions 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 their CUSTOM KNEE 206061 Procedure Kit (UDKN68AG) because ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe levels. This could cause skin irritation or allergic reactions if the cast is worn for extended periods.
The cast padding contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use. These chemicals can cause skin irritation or allergic reactions when the cast is worn for extended periods.
People who own or use this cast padding kit for knee injuries are affected. Those with sensitive skin or allergies to these chemicals are at higher risk.
Check for the catalog number UDKN68AG on the kit. The product was sold with lot numbers starting with 955241. The UDI-DI number is 00191072216335.
Look for the catalog number UDKN68AG and lot numbers starting with 955241 on the kit.
The recall is for potential skin irritation or allergic reactions from prolonged use of the cast padding, but it does not pose a risk of serious injury.
Check for the catalog number UDKN68AG and lot numbers starting with 955241 on the kit.
The recall does not specify a remedy, so you can continue using it if you have no signs of skin irritation or allergies.
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-2308-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2308-2024 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.
