Hamilton Medical, Inc. recalls Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure o…

Recall date

June 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0335-2018

FDA classification

Class II

Brand / firm

Hamilton Medical, Inc.

Sold / distributed

US Distribution to IL and TX.

Why it was recalled

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.