Baxter Healthcare recalls in-line ventilator adaptors (M07937 MODULE, OPTIMUS HANDSET 2) sold from Oct 2019. Potential for reduced oxygenation or pneumothorax 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 Healthcare is recalling in-line ventilator adaptors that may cause reduced oxygenation or pneumothorax when used at home. This could be serious for patients using ventilators.
The adaptor may cause reduced oxygen levels or lung damage (pneumothorax/barotrauma) when used with ventilators in home settings. This happens due to improper pressure regulation during breathing cycles.
Home care patients using Baxter's in-line ventilator adaptors (M07937 MODULE, OPTIMUS HANDSET 2) are most at risk. Patients with respiratory conditions requiring ventilator support are particularly vulnerable.
Check for the model numbers M07937 MODULE and OPTIMUS HANDSET 2 on the adaptor. These were sold from October 17, 2019, through present.
Identify if your adaptor has model numbers M07937 MODULE and OPTIMUS HANDSET 2.
Reach out to Baxter Healthcare for guidance on next steps if you have the recalled model.
Yes, the recall states there is a potential for reduced oxygenation or pneumothorax/barotrauma in home care use.
Check for model numbers M07937 MODULE and OPTIMUS HANDSET 2 on the adaptor, which were sold from October 17, 2019, through present.
Contact Baxter Healthcare for guidance on next steps if you have the recalled model.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1139-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1139-2022 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.
