Z-1139-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- April 26, 2022
- Termination Date
- August 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
In-Line ventilator adaptor
Reason for Recall
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Distribution Pattern
US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
Code Information
M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.