Baxter recalls in-line ventilator adaptors (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT) manufactured from Feb 28, 2020 onward due to potential reduced oxygenation or pneumothorax/barotrauma in home care use.
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.
Baxter is recalling in-line ventilator adaptors made from February 28, 2020, onward. These devices could cause reduced oxygenation or pneumothorax/barotrauma when used with the Volara system in home care settings.
The adaptor could cause reduced oxygen levels in the blood or lung damage (pneumothorax/barotrauma) when used with the Volara system in home care settings. This happens because the adaptor may not function properly under certain conditions, leading to inadequate oxygen delivery or pressure changes in the lungs.
Home care users of the Volara system with the recalled in-line ventilator adaptor are most at risk. Patients using this specific adaptor for home ventilation may experience reduced oxygenation or lung injury.
Check for the model number M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT on the adaptor. The device was manufactured from February 28, 2020, through present dates.
Look for the model number M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT on the adaptor.
Reach out to Baxter Healthcare Corporation for guidance on next steps.
The model number is M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT.
The adaptor was manufactured from February 28, 2020, through present dates.
The hazard is a potential for reduced oxygenation or pneumothorax/barotrauma when used with the Volara system in home care settings.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1138-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1138-2022 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
