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.
This recall is currently active, issued June 20, 2017. It was issued by Hamilton Medical Inc.
- Company
- Hamilton Medical Inc
- Recall Initiated
- June 20, 2017
- Recall Number
- Z-0335-2018
- Quantity
- 176 units
- Firm Location
- Reno, NV
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Serial No. 1000 thru 2090; P/N 951001
Root Cause
Component design/selection
Action Taken
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.
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Hamilton-MR1, REF: 161010, Intensive Care Ventilator
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