American Contract Systems recalls Hand Pack-Procedure Kit (WEHD16B) 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 Hand Pack-Procedure Kit (catalog number WEHD16B) because ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe levels for long-term use. This could pose health risks if the device is used for extended periods without proper cleaning.
The cast padding in the Hand Pack-Procedure Kit contains ethylene oxide and ethylene chlorohy:drin residues that exceed safe limits for long-term exposure. These chemicals can cause health issues if the padding is used without proper cleaning or if residues remain on the skin for extended periods.
Users of the Hand Pack-Procedure Kit for medical casts are affected. Individuals with medical conditions requiring frequent use of the cast padding may be at higher risk due to potential residue exposure.
Check for the catalog number WEHD16B on the kit. The lot numbers 662231, 983241, and 934241 are also associated with this recall.
Inspect the cast padding for visible ethylene oxide or ethylene chlorohydrin residues, though this is not explicitly stated in the recall.
The recall states that ethylene oxide and ethylene chlorohydrin residues exceed safe limits for long-term use, so it is not recommended for extended use without proper cleaning.
The recall does not specify a remedy, so no action is required based on the official notice.
Check for the catalog number WEHD16B and lot numbers 662231, 983241, or 934241 on the kit.
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-2310-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2310-2024 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.
