American Contract Systems recalls FOOT ANKLE-LF Procedure tray (Catalog CCFA51B) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage 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 FOOT ANKLE-LF Procedure trays with catalog number CCFA51B because ethylene oxide and ethylene chlorohy:drin residues in the cast padding may cause tissue damage with long-term use. This affects medical devices used in orthopedic procedures.
The procedure tray's cast padding contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term exposure. These chemicals can cause tissue damage if the tray is used for extended periods without proper cleaning.
Healthcare professionals using the FOOT ANKLE-LF Procedure trays for orthopedic casts. Patients receiving treatments with these trays may be at risk if the residues cause tissue damage.
Check for catalog number CCFA51B on the tray. The lot numbers 651231, 983241, 940241, and 901241 are associated with this recall. The tray has a UDI-DI code starting with 00191072193148.
Look for catalog number CCFA51B and lot numbers 651231, 983241, 940241, or 901241 on the tray.
The cast padding in the FOOT ANKLE-LF Procedure tray contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term exposure, potentially causing tissue damage.
The recall record does not specify a remedy, so no action is required beyond checking if your tray matches the described catalog and lot numbers.
The recall indicates a potential for tissue damage with prolonged use, but the record does not mention a risk of serious injury or death.
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-2285-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2285-2024 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.
