Z-0335-2018 Class II Ongoing
FDA device recall Z-0335-2018 was initiated by Hamilton Medical, Inc. on June 20, 2017 and is designated Class II. Reason for recall: Issue related to the performance of the motor in recalled product. During use, motor may cease to function. The recall status is ongoing. Affected quantity: 176 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- June 20, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176 units
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.
Distribution Pattern
US Distribution to IL and TX.
Code Information
Serial No. 1000 thru 2090; P/N 951001