American Contract Systems recalls ARTHO Knee Baptist South Pack Procedure tray (BPKA49B) due to potential EO/ECH chemical residues exceeding safety limits for permanent medical 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 ARTHO Knee Baptist South Pack Procedure trays with catalog number BPKA49B because chemical residues from ethylene oxide and ethylene chlorohydrin may exceed safe levels for long-term medical use. This could pose a risk to patients using the trays for permanent casts.
The trays contain ethylene oxide and ethylene chlorohydrin (EO/ECH) residues that may exceed safe levels for long-term medical use. This is based on standards from ANSI/AAMI/ISO 10993-7/(R)2012, which sets limits for chemical safety in medical devices.
Patients using ARTHO Knee Baptist South Pack Procedure trays for permanent cast applications are most at risk. The recall affects specific model trays sold with catalog number BPKA49B.
Check for catalog number BPKA49B on the tray. The lot numbers 953241 and 882241 are also associated with this recall.
Look for catalog number BPKA49B and lot numbers 953241 or 882241 on the tray.
The product contains ethylene oxide and ethylene chlorohydrin residues that may exceed safe levels for long-term medical use, as per ANSI/AAMI/ISO 10993-7/(R)2012 standards.
The recall record does not specify a remedy, so no action is required beyond checking if your tray has the catalog number BPKA49B and lot numbers 953241 or 882241.
The recall indicates potential chemical residue risks for long-term use, but the record does not specify a risk of serious injury or immediate harm.
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-2282-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2282-2024 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.
