Vyaire Medical recalls AirLife Resuscitation Devices with potential airflow obstruction during oxygen delivery. Affected models include specific part numbers and lot numbers for adult use. Consumers should check their device details to determine if recalled.
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Vyaire Medical is recalling AirLife Resuscitation Devices that may obstruct oxygen flow during use. This could lead to inadequate breathing support for patients in emergency situations.
The device has a manufacturing error that can block oxygen flow during use. This means patients who need emergency breathing support might not receive enough oxygen, which could be life-threatening.
Healthcare professionals and emergency responders who use these devices for patient resuscitation. Patients who rely on these devices for breathing support are at risk if the device fails to deliver oxygen properly.
Check the device label for part numbers: 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8036, 2K8001, 2K8035M, or 2K8004C2. Also look for lot numbers listed in the recall notice for each part number.
Look for part numbers on the device label to see if they match the recalled models listed in the notice.
If you have a recalled device, contact Vyaire Medical directly for further instructions.
Part numbers 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8036, 2K8001, 2K8035M, and 2K8004C2 are affected.
Check the device label for the specific part numbers listed in the recall notice and compare with the provided lot numbers.
The recall does not require immediate discontinuation; however, you should check if your device is affected before use.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2552-2018 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-2552-2018 from Vyaire Medical. 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.
