Cast Padding Component Recalled for Excess Ethylene Oxide Residuals
American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.
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 FDA Class II recall involves a permanent-contact medical device with ethylene oxide and ethylene chlorohydrin residuals exceeding established safety limits. The product's intended extended skin contact combined with documented residual exceedance creates a risk-of-harm scenario.
Plain-English summary
American Contract Systems Inc is recalling the ACL ST LUKES METHODIST 1CS cast padding component (Catalog Number LMAC10AA). The product was distributed nationwide and affects 8 units in total.
The cast padding component contains ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals that exceed the established safety limits for medical devices intended for permanent skin contact, as specified by ANSI/AAMI/ISO 10993-7:(R)2012 standards.
The affected product is identified by Lot Numbers 666231 and 931241 (UDI-DI 00191072209290). For information about the recall, contact American Contract Systems Inc.
The recalled product
- Product
- ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
- Manufacturer
- American Contract Systems Inc
- Affected units
- 8
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: 00191072209290 LOT#"s: 666231 931241
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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