American Contract Systems recalls ARTHRO KNEE BEACHES PACK BHS- Procedure tray (Catalog BPKB46B) 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 ARTHRO KNEE BEACHES PACK BHS- Procedure trays with catalog number BPK: 46B because chemical residues from ethylene oxide and ethylene chlorohydrin may cause health issues if used long-term. This recall affects users who have the specific model and lot numbers listed.
The cast padding component in the procedure tray contains ethylene oxide and ethylene chlorohydrin residuals that exceed safe levels for long-term use. These chemicals can cause health issues if the tray is used for extended periods, especially in medical applications where prolonged contact occurs.
Users of the ARTHRO KNEE BEACHES PACK BHS- Procedure tray with catalog number BPKB46B and specific lot numbers (992241, 914241) are affected. Individuals using medical casts or similar applications are most at risk due to potential chemical exposure.
Check for the catalog number BPKB46B on the procedure tray. The affected lot numbers are 992241 and 914241. This product was sold with the UDI-DI: 00191072197948.
Verify the catalog number (BPKB46B) and lot numbers (992241, 914241) on the procedure tray.
The cast padding component contains ethylene oxide and ethylene chlorohydrin residuals that exceed safe levels for long-term use, potentially causing health issues.
Check the catalog number and lot numbers on the procedure tray. If it matches the recalled model and lot numbers, contact American Contract Systems for further instructions.
Yes, prolonged use of the cast padding component may cause health issues due to excessive chemical residuals.
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-2283-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2283-2024 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.
