American Contract Systems recalls BPKN15C Knee Basin Pack BHS- Procedure trays 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 BPKN15C Knee Basin Pack BHS- Procedure trays because ethylene oxide and ethylene chlorohydrin residues in the cast padding exceed safe limits. This could cause tissue damage if the device is used for extended periods.
The cast padding in the BPKN15C tray contains ethylene oxide and ethylene chlorohydrin residues that exceed safe levels for long-term use. These chemicals can cause tissue damage if the device is used for extended periods without proper cleaning.
Healthcare professionals who use these trays for patient care, particularly those applying casts. Patients with temporary knee immobilization devices may also be affected.
Check for the catalog number BPKN15C on the tray. The lot numbers 639231 and 928241 are associated with this recall. These trays were sold with the UDI-DI: 00191072200518.
Inspect the cast padding for visible ethylene oxide or ethylene chlorohydrin residues, though this is not a practical step for users.
The recall is for potential tissue damage from prolonged use due to chemical residues, but it is not an immediate hazard.
Look for the catalog number BPKN15C on the tray, with lot numbers 639231 or 928241 and UDI-DI: 00191072200518.
The recall does not specify a remedy, so users should contact American Contract Systems for guidance.
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-2284-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2284-2024 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.
