American Contract Systems recalls procedure trays with catalog number BFLE56X due to excessive ethylene oxide/ethylene chlorohydrin residuals potentially causing health risks.
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 procedure trays with catalog number BFLE56X because ethylene oxide and ethylene chlorohydrin residues may exceed safe levels for long-term use. This could pose health risks to users, especially those with medical casts.
The procedure trays contain ethylene oxide and ethylene chlorohydrin residues that may exceed safe levels for long-term exposure. This could potentially cause health issues for individuals with medical casts that require these trays.
Healthcare professionals using the procedure trays for cast applications are most at risk. Patients with medical casts that require these trays are also affected.
Check for catalog number BFLE56X on the tray. The lot numbers range from 943241. The product was sold under the UDI-DI: 00191072214553.
Look for catalog number BFLE56X and lot numbers starting with 943241 on the procedure tray.
The procedure trays contain ethylene oxide and ethylene chlorohydrin residues that may exceed safe levels for long-term exposure, potentially causing health risks.
Check the product for catalog number BFLE56X and lot numbers starting with 943241. If you have the recalled product, you should check with American Contract Systems for further instructions.
The recall is due to potential health risks from chemical residues, not immediate physical injury risks. The hazard level is low risk.
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-2277-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2277-2024 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.
