Procedure Tray Recalled for Excess Ethylene Oxide Residue
American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure 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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—excess ethylene oxide residuals on a medical device intended for permanent body contact—represents a risk-of-harm product where injury has not yet been reported, consistent with the rubric's High severity criterion.
Plain-English summary
American Contract Systems Inc. is recalling the LOWER EXTREMITY - 247542 Procedure Tray (Catalog Number BFLE56X) distributed nationwide. The recalled units bear LOT#943241, with 48 units affected.
Ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals on the cast padding component exceed the safety limits for permanent exposure devices as defined by ANSI/AAMI/ISO 10993-7:2012.
No illnesses or injuries have been reported. Users should discontinue use and contact American Contract Systems Inc. for replacement or return instructions.
The recalled product
- Product
- LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Procedure Tray
- Hazard
- Affected units
- 48
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: 00191072214553 LOT#"s: 943241
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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