FDA Device

VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.

Hazard

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.

What You Should Do

Remedy

Draeger Inc. (US) issued Urgent Medical Device Recall Letter via Certified Mail on January 29, 2021. The letter states reason for recall, health risk and action to take: Please check the quality of the adhesive joint before use by holding the Y-piece with one hand and then pulling (not twisting) each of the two hoses one after another so that the hose just starts to stretch visibly. Hoses that you have tested in this manner may be used if they pass the leakage test before use. Only use the hoses with devices that we have declared compatible in the Instructions for Use or accessories list of the basic device. Ensure that the patient is adequately monitored and select suitable alarm limits. During installation and operation, make sure to avoid any unnecessary tensile forces, and do not use the hoses for longer than is specified in the Instructions for Use. Please inspect your existing stock before use by following the above inspection instructions. Please also complete and return the attached Customer Reply and Order form to confirm to us that you have received this information. If you wish, we will be happy to replace any of your unused stocks that were manufactured between 01.01.2018 and 13.11.2020. The form may also be used to order Free of Charge replacements. Questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).

Products

VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or venti
Brand
Draeger Medical, Inc.
UPC
All lots

Units Affected

4.450 units