Z-1138-2022 Class I Terminated
FDA device recall Z-1138-2022 was initiated by Baxter Healthcare Corporation on Apr 26, 2022 and is designated Class I. 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. The recall status is terminated (terminated Aug 20, 2024). Affected quantity: 259 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- Apr 26, 2022
- Termination Date
- Aug 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1138-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026