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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00332-1
Product Name/Description	Latex Test Lungs and Latex Rebreathing Bags Latex Rebreathing Bags Part numbers: 2165694 and 2165708 Latex Test Lung Part number: 8403201
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	18/03/2014
Responsible Entity	Draeger Medical Australia Pty Ltd
Reason/Issue	A user suffered an acute allergic reaction after using a Dräger latex test lung; the user did not suffer permanent injury. Review of this incident identified that the device labels did not have internationally recognised indication of latex material.
Recall Action	Recall for Product Correction
Recall Action Instructions	Drager is correcting the product labels to include a warning that the device contains latex.
Contact Information	03 9244 7248 - Draeger Medical Australia