Agency classClass IOur severity:Severe FDA (Devices)·Z-1139-2022·Announced 2022-06-08

Baxter ventilator adaptor recalled for potential oxygenation failure and barotrauma risk

Baxter Healthcare is recalling in-line ventilator adaptors (Optimus Handset 2 module) used in home care. The devices may cause reduced oxygenation or barotrauma when used with Volara systems.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

Plain-English summary

Baxter Healthcare Corporation is recalling in-line ventilator adaptors (code M07937 MODULE, Optimus Handset 2) manufactured from October 17, 2019 to present. The affected devices are distributed nationwide across multiple U.S. states.

The adaptors may cause reduced oxygenation or pneumothorax and barotrauma when used with the Volara system in home care environments. These risks were identified as potential hazards associated with the device's performance in in-line ventilator applications in home care settings.

Consumers and healthcare providers should be aware of this potential risk when using the affected devices.

The recalled product

Product: In-Line ventilator adaptor
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Respiratory equipment
Hazard: reduced-oxygenation
pneumothorax
barotrauma
Affected units: 9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

M07937 MODULE
OPTIMUS HANDSET 2
UDI-DI: 00887761984622. Manufacturing dates October 17
2019 to present.

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · reduced oxygenation