Elevated risk U.S. Food and Drug Administration

Volara system single-patient use circuit and blue ventilator adapter recall: Reports of the handset plug disconnecting from the nebulizer port on the blue

Recall published 2+ years ago

Reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter

Volara Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: If the handset plug disconnects and goes unnoticed prior to or during therapy, it may lead to an interruption or delay of care.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
July 15, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Volara
Product type
Medical devices
Reports of harm
To date, there have been no injuries reported in association with this issue.

Products covered by this recall

Volara system single-patient use circuit and blue ventilator adapter assembly

What the company announced

DEERFIELD, Ill., July 15, 2024 – Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly (see Figure 1). The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no injuries reported in association with this issue. Baxter is working with customers to replace the affected products.

When using the Volara system in-line with a ventilator and without a nebulizer connected to the blue ventilator adapter, the handset plug is required to help ensure proper operation and ventilator gas flow. If the handset plug disconnects and goes unnoticed prior to or during therapy, it may lead to an interruption or delay of care. This may result in reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter.

Baxter has contacted affected customers, instructing them to stop using the affected patient circuits and arrange for the return and replacement of the accessories by contacting Baxter directly. If a patient does not have another option for therapy, they may continue to use it with caution. Customers are instructed to visually inspect the nebulizer port prior to therapy and check for any ventilator gas flow leaks for the duration of therapy.

The Urgent Medical Device Recall applies to the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly, product code M07937. The impacted accessories were distributed in the United States between Aug. 26, 2022 and Dec. 30, 2023.

Baxter has notified the U.S. Food and Drug Administration (FDA) of this action. Any product quality complaints or adverse events experienced with the use of these products may be reported using one of the following options:

Contacting Baxter Advanced Respiratory customer service at 800-426-4224 between the hours of 8 a.m. and 5 p.m. Central Time, Monday through Friday. Select option 2 for Acute Care Customer Service or option 3 for Home Care Customer Service.

Reporting to the FDA MedWatch Serious Injury Reporting Program:

Online: By completing and submitting the report online at: https://www.accessdata.fda.gov/scripts/medwatch/

Regular mail or fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form, or submit by fax to 800-332-0178

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • M08473
  • M08474
  • M07937

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Volara — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Remedy named in the notice: Baxter has contacted affected customers, instructing them to stop using the affected patient circuits and arrange for the return and replacement of the accessories by contacting Baxter directly.

Company contact: Baxter International Inc. — Consumers: Baxter Advanced Respiratory Customer Service, 800-426-4224

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Volara medical devices recalled?

Reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter If the handset plug disconnects and goes unnoticed prior to or during therapy, it may lead to an interruption or delay of care.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number M08473, M08474, M07937. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Baxter has contacted affected customers, instructing them to stop using the affected patient circuits and arrange for the return and replacement of the accessories by contacting Baxter directly.

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