Recall Z-1180-2021— Draeger Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Draeger Medical, Inc., initiated 2021-01-29, terminated 2021-11-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-29
- Terminated
- 2021-11-01
- Firm location
- Telford, PA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.