American Contract Systems recalls ARTHROSCOPY SUP JOI PACK Procedure tray (Catalog BPAS17C) due to excessive ethylene oxide/ethylene chlorohydrin residuals, which may pose health risks during long-term 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 SUP JOI PACK Procedure trays with catalog number BPAS17C because they contain too much ethylene oxide/ethylene chlorohydrin residue. This residue could cause health issues if the device is used for extended periods, especially in medical settings where the material is in contact with patients.
The trays contain ethylene oxide and ethylene chlorohydrin residues that exceed safety limits for permanent exposure devices. These chemicals can cause health issues if the device is in contact with the body for extended periods, such as during medical procedures.
Healthcare professionals using the ARTHROSCOPY SUP JOI PACK Procedure trays for medical procedures are most at risk. Patients receiving long-term treatment with these trays could also be affected.
Check for the catalog number BPAS17C on the tray. The lot numbers 665231 and 950241 are also associated with this recall. These trays were sold by American Contract Systems.
The recall is due to excessive ethylene oxide/ethylene chlorohydrin residues, which may pose health risks during long-term use.
The product is not safe for long-term use due to excessive ethylene oxide/ethylene chlorohydrin residues. Healthcare professionals should check for the recall and follow the action steps.
The recall does not specify a remedy, so you should check the product for the catalog number BPAS17C and lot numbers 665231 or 950241. Contact American Contract Systems for further instructions.
Look for the catalog number BPAS17C and lot numbers 665231 or 950241 on the ARTHROSCOPY SUP JOI PACK 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-2281-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2281-2024 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.
