FDA Device

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.

Hazard

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

What You Should Do

Remedy

Hamilton Medical sent a Recall Notice dated June 20, 2017, notifying them of the device correction. Consignees were informed that a Hamilton Representative would be in contact with them regarding the return of any devices. For further questions, please call (775) 858-3200.

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
Brand
Hamilton Medical, Inc.
UPC
Serial No. 1000 thru 2090; P/N 951001

Units Affected

176 units