Recall Z-0335-2018— Hamilton Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Hamilton Medical, Inc., initiated 2017-06-20. It names one FDA 510(k) clearance: K150893. 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: Issue related to the performance of the motor in recalled product. During use, motor may cease to function..
- Recalling firm
- Hamilton Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-06-20
- Firm location
- Reno, NV, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Data sourced from openFDA. This site is unofficial and independent of the FDA.