Procedure Tray Recalled for Excessive Ethylene Oxide Residuals
American Contract Systems Inc is recalling 129 units of ARTHO KNEE BAPTIST SOUTH PACK Procedure trays (lot numbers 953241, 882241) due to ethylene oxide and ethylene chlorohydrin sterilization residuals exceeding safe limits for permanent-contact medical 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: FDA Class II recall involving risk-of-harm from chemical sterilant residuals exceeding safety limits on a permanent-contact medical device, with no illnesses or injuries reported to date. The hazard is potential exposure rather than confirmed harm.
Plain-English summary
American Contract Systems Inc is recalling 129 units of the ARTHO KNEE BAPTIST SOUTH PACK Procedure tray (Catalog Number BPKA49B) distributed nationwide in the United States. The affected lot numbers are 953241 and 882241.
The recall is due to elevated residuals of ethylene oxide (EO) and ethylene chlorohydrin (ECH)—chemical sterilants used in device manufacturing—in the cast padding component. These residual levels exceed the limits established by ANSI/AAMI/ISO 10993-7 (R2012) for medical devices intended for permanent or long-term body contact.
Patients and healthcare providers using these procedure trays are potentially exposed to chemical residuals above regulatory safety limits. No illnesses or injuries have been reported related to this recall.
Healthcare facilities should discontinue use of the affected lot numbers and contact American Contract Systems Inc regarding replacement or return options.
The recalled product
- Product
- ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide
- chemical-residue
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: 00191072197931 LOT#"s: 953241 882241
Distribution
Distributed nationwide across the United States.
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