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Recall Observatory FDA recall evidence

Device product

ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

Z-1180-2021

January 29, 2021

Class II

Product summary

Firm
Draeger Medical, Inc.
Event
Event 87267
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-1180-2021

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.