Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16398
Brand Name:Draeger Latex Lungs (for V-series ventilators)
Model:8403201
Affected:
Software version:
Recalling Organisation:Draeger New Zealand Ltd
Unit 4
24 Bishop Dunn Place
East Tamaki
Auckland 2013
Contact Information:0800 559 186
Manufacturer:Draegerwerk AG & Co KGaA
Brand Name:Draeger Reusable Latex Rebreathing Bags
Model:2165694 and 2165708
Affected:
Software version:
Recalling Organisation:Draeger New Zealand Ltd
Unit 4
24 Bishop Dunn Place
East Tamaki
Auckland 2013
Contact Information:0800 559 186
Manufacturer:Draegerwerk AG & Co KGaA
Issue:Manufacturer has become aware of an incident where a user suffered an acute allergic reaction after using a Drager latex test lung. During investigation of the incident noted that the breathing bag that forms part of the test lung and or other latex natural rubber breathing bags are labelled "NR" (natual rubber). Although this is the standard abbreviation for natural rubber this labelling does not comply with the application of international standards for medical devices.Manufacturer points out that the blue reusable breathng bags which bear the marking "NR" do contain natural rubber (Latex) Drager breathing bags made f latex (blue) are clearly dstngiishablefrom the latex-free version made form silicon (transparent) by their colour.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:18/3/2014
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