Medical device shortage: Quadrox-I Neonatal Oxygenator
The Quadrox-I Neonatal Oxygenator is currently reported as a medical device shortage under sections 62.21 to 62.26 of the Medical Devices Regulations. For a full list of shortages, refer to the List of shortages and discontinuations.
Posted on 2023-08-28Footnote 1
Type of report
Actual medical device shortage
Name of medical device (including any component, accessory or part that is in shortage, including the model name) if applicable
Quadrox-I Neonatal Oxygenator
Other names (for example trade name), if applicable
N/A
Package description (for example, packaging formats, sizes, quantities)
1 device per box
Class of medical device (I, II, III or IV), if known
III
Device identifier(s) (for example, serial number, catalogue number, part number, model number or unique device identifier)
- HMO 10000
- HMO 10000-USA
- HMO 11000
- HMO 11000-USA
Medical device licence number (for Class II, III and IV), if applicable
82784
Authorization identification number (for devices authorized for importation or sale under an interim order made under section 30.1 of the Food and Drugs Act), if applicable
N/A
Single-use product
Yes
Importers that have reported the shortage (Names of importers listed who have reported the shortage separately from the manufacturer or who are reporting on behalf of the manufacturer in a delegated capacity), if applicable
Getinge Canada Ltd
Manufacturer's name
Maquet Cardiopulmonary GMBH
Manufacturer's mailing address
Kehler Strasse 31
Rastatt
Germany
76437
Reason for shortage
Device was subject to a recall
- Footnote 1
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This date reflects when a shortage report is first posted online. This page includes specific information related to the device that is in shortage. Updates to the status and end date of a shortage can be found on the List of shortages webpage.
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