The Recall Desk
HighFDA (Devices)·Z-2306-2024·Announced 2024-07-17

Surgical Procedure Kit Recalled for Ethylene Oxide Residual Contamination

American Contract Systems Inc is recalling the ACL PACK Surgical Procedure Kit due to elevated ethylene oxide and ethylene chlorohydrin residuals that exceed regulatory 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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard represents a risk-of-harm product (chemical residuals exceeding standards), but the potential injury is theoretical. Per the rubric, recalls with no reported harm and theoretical hazards score at most 3.

Plain-English summary

American Contract Systems Inc is recalling the ACL PACK - 206039-Procedure Kit (Catalog Number UDAC66AA) due to elevated ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residual levels exceed the limits specified by ANSI/AAMI/ISO 10993-7:(R)2012 standards for permanent-contact medical devices.

The recalled product was distributed nationwide in the United States. The affected lot number is 896241, involving 6 units. Consumers who have received this device should contact the manufacturer or their healthcare provider for further guidance.

The recalled product

Product
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
Manufacturer
American Contract Systems Inc
Category
Medical Device — Surgical Procedure Kit
Hazard
  • ethylene-oxide-residuals
  • chemical-exposure

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: 00191072216212 LOT#"s: 896241

Distribution

Distributed nationwide across the United States.

Related recalls

Same category