American Contract Systems recalls hand wrist forearm-LF procedure trays with catalog number CCHD17B 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 hand wrist forearm-LF procedure trays (catalog number CCHD17B) because ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage with long-term use. This recall affects medical devices used in casting procedures.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residues that exceed safety limits for permanent exposure devices. These residues could cause tissue damage if the device is used for extended periods.
Healthcare professionals using the procedure trays for casting patients are most at risk. The recall applies to specific model numbers and production lots.
Check for catalog number CCHD17B on the tray. The product was sold with production lots 651231 and 948241. The UDI-DI code 00191072193179 identifies the affected units.
Identify the catalog number CCHD17B and production lots 651231 or 948241 on the tray.
Ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safety limits for permanent exposure devices, potentially causing tissue damage with prolonged use.
The recall record does not specify a remedy, so no action is required beyond checking if your product matches the affected details.
Check for catalog number CCHD17B and production lots 651231 or 948241 on the tray.
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-2286-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2286-2024 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.
