Volara System recallZ-1139-2022 · Baxter Healthcare Corporation · initiated Apr 26, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1139-2022
- Status
- Terminated
- Initiated by the company
- Apr 26, 2022
- Posted by the FDA
- May 30, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9 units
- Product code
- NHJ
- FDA submissions
- K200988
- 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.
Product description
In-Line ventilator adaptor
Code information (models, lots, serial numbers)
M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Volara System M07937Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90061).
- Z-1138-2022 · TerminatedIn-Line ventilator adaptor
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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