Reported Jan 24, 2018 · Ongoing

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure…

Hamilton Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical, Inc. · 4990 Energy Way · Reno, NV · 89502-4123

Is this the product you have?

  • 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.
Lot codes and dates
    • Serial No. 1000 thru 2090
    • P/N 951001
Amount recalled
176 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:28 PM UTC

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