The Recall Desk

FDA (Devices) recall action 80500

Vyaire Medical recalled 2 products on 2018-08-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-08-15
Critical
0
Units
31,428

Why these products were recalled

An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2018-08-15

    Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk

    Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric,
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2018-08-15

    Vyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction

    Vyaire Medical is recalling 15,714 AirLife Adult Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part
    Category
    Distribution
    28 states