American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals
American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a surgical tray with a defined chemical hazard: ethylene oxide residuals exceeding the limits specified in safety standards. Although no illnesses or injuries have been reported, the product poses a potential health risk to users through exposure to sterilization chemical residues that exceed established safety limits.
Plain-English summary
The MAJOR KNEE surgical procedure tray (Model 302497, Catalog Number ASKN23B) manufactured by American Contract Systems Inc has been recalled. A total of 26 units were distributed nationwide in the United States.
The recall was initiated because ethylene oxide and ethylene chlorohydrin residuals from the sterilization process on the cast padding component exceeded the limits specified for permanent exposure medical devices under the ANSI/AAMI/ISO 10993-7:(R)2012 standard.
Healthcare facilities and medical professionals who received these trays should stop using them immediately and contact American Contract Systems Inc for replacement or return instructions. The recalled lot is identified as 946241 (UDI-DI: 00191072216885).
No illnesses or injuries related to this product have been reported to the FDA.
The recalled product
- Product
- MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residual
- sterilization-chemical
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00191072216885 LOT#"s: 946241
Distribution
Distributed nationwide across the United States.
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