FDA Recall
Open, Classified
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.
Recall: Z-0335-2018
·
Initiated June 20, 2017
Recall
- Recall Number
- Z-0335-2018
- Event Number
- 77617
- Firm
- Hamilton Medical, Inc.
- FEI Number
- 2937708
- Product Code
- BSK
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- June 20, 2017
- Address
- 4990 Energy Way, Reno, NV, 89502-4123
Description
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
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Action
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.
Distribution
US Distribution to IL and TX.
Quantity
176 units