American Contract Systems recalls Hand Pack-Procedure Kit (WEHD16C) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing health risks 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 Hand Pack-Procedure Kit (catalog number WEHD16C) because the cast padding component has unsafe levels of ethylene oxide and ethylene chlorohydrin residues. This could pose health risks if the device is used for extended periods.
The cast padding component contains excessive ethylene oxide and ethylene chlorohy: residues beyond safe limits for long-term use. This could lead to health issues if the device is used for extended periods without proper cleaning or decontamination.
Users of the Hand Pack-Procedure Kit for medical casts or similar applications are likely affected. Individuals with prolonged exposure to the cast padding may be at higher risk.
Check for the catalog number WEHD16C on the kit. The lot numbers range from 894241. The product was sold with UDI-DI: 00191072217035.
Look for the catalog number WEHD16C and lot numbers starting with 894241 on the kit.
The cast padding component has ethylene oxide and ethylene chlorohydrin residues exceeding safe limits for long-term use, potentially causing health risks.
The recall record does not specify a remedy, so check the product details and contact the manufacturer for further instructions.
The recall indicates a health risk from prolonged exposure, not immediate injury risks like falls or fires.
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-2311-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2311-2024 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.
