American Contract Systems recalls Hand Draping SJH-Procedure Kit (SJHD67F) due to ethylene oxide/ethylene chlorohydrin residuals exceeding safety limits for permanent exposure devices.
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 Draping SJH-Procedure Kit (catalog number SJHD67F) because ethylene oxide and ethylene chlorohy:drin residues in the cast padding may cause health issues with long-term use. This recall is important for medical professionals who use the kit for permanent cast applications.
The cast padding component in the kit contains ethylene oxide and ethylene chlorohydrin residues that exceed safety limits for permanent exposure devices. This could lead to health issues if the padding is used for extended periods, as per ANSI/AAMI/ISO 10993-7 standards.
Medical professionals who use the Hand Draping SJH-Procedure Kit for permanent cast applications are most at risk. The recall affects specific catalog numbers and lot numbers listed in the product description.
Check for the catalog number SJHD67F on the kit. The affected lots include 662231, 981241, 917241, and 882241. The product was sold with a specific UDI-DI code 00191072192349.
Verify the catalog number and lot numbers listed in the product description to confirm if your kit is affected.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residues that exceed safety limits for permanent exposure devices, as per ANSI/AAMI/ISO 10993-7 standards.
The recall record does not specify a remedy, so check the product details to see if your kit is affected and contact the manufacturer for further instructions.
The affected lots are 662231, 981241, 917241, and 882241.
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-2300-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2300-2024 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.
