Z-1954-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- April 26, 2018
- Termination Date
- September 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Reason for Recall
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
Distribution Pattern
Distributed to the states of CT, IL, MN, NV, SD, and WA.
Code Information
Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009