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U.S. Department of Health and Human Services

Class 2 Device Recall ID Basic

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  Class 2 Device Recall ID Basic see related information
Date Initiated by Firm January 29, 2021
Create Date March 05, 2021
Recall Status1 Terminated 3 on November 01, 2021
Recall Number Z-1180-2021
Recall Event ID 87267
Product Classification Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFP
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.
Code Information All lots
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact SAME
215-721-5400
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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).
Quantity in Commerce 25 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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