American Contract Systems recalls specific upper extremity casts due to excessive ethylene oxide/ethylene chlorohydrin residues, which 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 certain upper extremity casts because they contain unsafe levels of ethylene oxide and ethylene chlorohydrin residues. These residues could cause health issues if the casts are used for extended periods.
The cast padding contains ethylene oxide and ethylene chlorohydrin residues that exceed safe limits for long-term exposure. This can lead to health problems such as skin irritation or allergic reactions over time, especially with extended use.
People who own or use the recalled upper extremity casts, particularly those with injuries requiring long-term casting. Individuals with chronic conditions or prolonged use of the casts are at higher risk.
Check for the catalog number IHUE40AG on the cast packaging. The lot numbers 658231, 953241, and 899241 are also associated with this recall.
Look for the catalog number IHUE40AG and lot numbers 658231, 953241, or 899241 on the cast packaging.
The cast padding contains ethylene oxide and ethylene chlorohydrin residues that exceed safe limits for long-term use, potentially causing health issues.
Check for the catalog number IHUE40AG and lot numbers 658231, 953241, or 899241 on the cast packaging.
The recall record does not specify a remedy, so contact American Contract Systems for guidance.
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-2288-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2288-2024 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.