FDA recall Z-1279-2022

Product

Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900

Reason for recall

Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.

Distribution

US Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia

Key facts

Status

Terminated

Initiation date

2022-05-02

Report date

2022-06-29

Termination date

2024-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1279-2022