The Recall Desk
HighFDA (Devices)·Z-2289-2024·Announced 2024-07-17

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.

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 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
Category
Medical Device — Orthopedic cast padding
Hazard
  • ethylene-oxide-residuals
  • skin-contact

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.

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