Class I Recall of Vyaire Medical, Inc. AirLife Resuscitation Devices

PUBLISHED: Aug 10, 2018
Relevant to: All Healthcare Organizations

Vyaire Medical, Inc is recalling the AirLife Resuscitation Device due to a manufacturing error which may cause extra plastic material in the oxygen output connection to reduce or block the flow of oxygen to the patient. The blocked connection may result in a delay in or inability to provide necessary ventilation to the patient and potentially result in serious patient injury, such as inadequate oxygen supply (hypoxia), or death.

The FDA has classified this as a Class I recall. Vyaire has received no complaints of this problem; there have been no patient injuries.

Recalled Product(s):

AirLife Resuscitation Devices:

  • Product Codes: 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8018, 2K8008, 2K8036, 2K8001, RE1DK5445D,2K8035M,2K8039,2K8004C2
  • Manufacturing Dates: February 5, 2018 to February 28, 2018
  • Distribution Dates: February 2, 2018 to April 20, 2018
  • Devices Recalled in the U.S.: 15,714 units nationwide

Vyaire Medical, Inc sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to:

  • Review the recall notice and ensure appropriate staff is aware of the notice.
  • Identify and remove affected lots of the AirLife Resuscitation Devices
  • Destroy all affected product(s) in-stock in accordance with the facility's destruction protocol.
  • Complete the Customer Response Form and return to GMB-GLB-ALFieldActions@Vyaire.com.

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