American Contract Systems Inc. is recalling 5,391 various surgical procedure trays, including Total Knee, Arthroscopy, and Hand/Wrist kits, because a component in the trays exceeded safe limits for chemical residuals. Specifically, the cast padding component contains levels of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) that are higher than allowed for medical devices intended for permanent exposure. These trays were distributed nationwide across the United States between May 2024 and July 2024.
Exposure to excessive Ethylene Oxide and Ethylene Chlorohydrin residuals can cause localized irritation or more serious systemic toxic effects depending on the duration and nature of the exposure. No specific injuries have been reported to date.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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