FDA recall Z-0335-2018

Hamilton Medical, Inc. · Class II · device

Product

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.

Reason for recall

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

Distribution

US Distribution to IL and TX.

Key facts

Status
Ongoing
Initiation date
2017-06-20
Report date
2018-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0335-2018