Baxter Healthcare Corporation In-Line ventilator adaptor Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
In-Line ventilator adaptor
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT, UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.
Products Sold
M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.
Baxter Healthcare Corporation is recalling In-Line ventilator adaptor due to 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 en. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026