Recall archive / FDA device enforcement
In-Line ventilator adaptor — FDA record Z-1138-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- In-Line ventilator adaptor
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 259 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1138-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 8, 2022
- Recall initiation date
- Apr 26, 2022
- Center classification date
- May 30, 2022
- Termination date
- Aug 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.