Vyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction

Plain-English summary

Vyaire Medical is recalling 15,714 units of AirLife Resuscitation Devices, Adult. These are manual resuscitation devices intended for single-patient use to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The recall includes eight specific configurations with part numbers 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8036, 2K8001, 2K8035M, and 2K8004C2.

The recall was initiated due to a manufacturing error that has the potential to obstruct the airflow of supplemental oxygen delivery during use. The affected devices were distributed in the United States to the following states and territories: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PR, SD, TX, VA, and WA.

Healthcare providers and consumers should stop using the affected devices immediately. Users should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. For more information, contact Vyaire Medical or refer to the FDA recall record Z-2552-2018.

The recalled product

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

Manufacturer

Vyaire Medical

Category

Medical Device — Resuscitation Equipment

Hazard

• airflow-obstruction
• oxygen-delivery-failure

Affected units

15,714

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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