The Recall Desk
SevereFDA (Devices)·Z-1138-2022·Announced 2022-06-08

In-Line Ventilator Adaptor Recall: Risk of Reduced Oxygenation or Barotrauma

Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as a Class I recall. According to the severity rubric, FDA Class I recalls must score at least 4 (Severe) per the guidance, regardless of reported illnesses.

Plain-English summary

Baxter Healthcare Corporation is recalling 259 in-line ventilator adaptor units (Model M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492, manufacturing dates February 28, 2020 to present).

The adaptor presents a potential risk of reduced oxygenation, pneumothorax, or barotrauma when used with Volara systems in home care environments. This is a Class I recall. No illnesses or injuries have been reported.

The affected adaptor units were distributed nationwide across 33 states.

The recalled product

Product
In-Line ventilator adaptor
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Respiratory Equipment
Hazard
  • reduced-oxygenation
  • pneumothorax
  • barotrauma

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 (3)

  • M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT
  • UDI-DI: 00887761981492. Manufacturing dates February 28
  • 2020 to present.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category