Z-1138-2022 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
- 259 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
M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.