American Contract Systems recalls ARTHROSCOPY WOLF:SON PACK BHS Procedure tray (Catalog BPAR65A) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, which may pose health risks 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 ARTHROSCOPY WOLFSON PACK BHS Procedure trays with catalog number BPAR65A because ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe levels for long-term use. This could lead to health issues if the device is used repeatedly without proper cleaning.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for permanent exposure devices as per ANSI/AAMI/ISO 10993-7 standards. This could cause health issues if the device is used repeatedly without proper cleaning.
Healthcare professionals who use these procedure trays in surgical settings are most at risk due to potential prolonged exposure to the chemical residues. Patients using the trays for cast padding may also be affected if the residues are not properly removed.
Check for the catalog number BPAR65A on the ARTHROSCOPY WOLFSON PACK BHS Procedure tray. The lot numbers 661231, 971241, 928241, and 893241 are also associated with this recall.
Inspect the cast padding for visible ethylene oxide/ethylene chlorohydrin residues, though the recall does not specify a visual indicator.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for permanent exposure devices as per ANSI/AAMI/ISO 10993-7 standards.
The recall does not specify a remedy, so no action is required beyond checking for the catalog number and lot numbers listed.
Look for the catalog number BPAR65A and lot numbers 661231, 971241, 928241, or 893241 on the ARTHROSCOPY WOLFSON PACK BHS Procedure 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-2280-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2280-2024 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.
