FDA-Device2018-01-24Class II
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.
Hamilton Medical, Inc.
Hazard
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Sold states
US Distribution to IL and TX.
Affected count
176 units
Manufactured in
4990 Energy Way, N/A, Reno, NV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2018Don't want to check this manually?
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