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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 129
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.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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