FDA recall Z-1179-2021

Product

VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

Reason for recall

Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-01-29

Report date

2021-03-17

Termination date

2021-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2021