American Contract Systems recalls ACL PACK 206039-Procedure Kit (UDI-DI: 00191072216212) due to potential skin irritation from ethylene oxide residuals. Affected units were sold with specific lot numbers.
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 recalls a specific cast padding kit because ethylene oxide residues may cause skin irritation. This is a safety issue for people using medical casts.
Ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause skin irritation if the product is used without proper cleaning. This happens because the residues exceed safety limits for long-term medical use.
People who own or use the ACL PACK 206039-Procedure Kit with the specified lot numbers are affected. Those with medical casts are most at risk.
Check for the catalog number UDAC66AA and lot numbers 896241 on the product. The product was sold with a unique identifier (UDI-DI) starting with 00191072216212.
Look for the catalog number UDAC66AA and lot number 896241 on the product label.
The recall states ethylene oxide residues may cause skin irritation, but the risk is low and not life-threatening.
Check for catalog number UDAC66AA and lot number 896241 on the product label.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
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-2306-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2306-2024 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.
