Recall Z-1385-2022
Hamilton Medical AG · initiated January 5, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Codes / lots: UDI:07630002801546. All devices with software version 1.10c
Reason for recall
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
FDA-determined cause: Employee error
Action taken
On 01/05/21, Field Safety Corrective Action notices were sent to customers who were asked to do the following: Follow the instructions in the HAMILTON-H900 Operator s Manual 624431 section 3.4. Before connecting a new patient to the humidifier; " Verify that the alarms operate correctly. " Ensure that the water supply to the humidifier chamber is functioning properly. Distribute this notification to all end users within your organization. A Medical Representative will be in contact to schedule service with a software update. Customers with additional questions or concerns were encouraged to call Technical Support at 1-800-426-6331, option #2.
Details
- Recall number
- Z-1385-2022
- Initiated
- January 5, 2021
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Quantity
- 203
- Distribution
- US: WI, FL, CA, NV, PA, TX, PA
- Recalling firm
- Hamilton Medical AG, Bonaduz