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

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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