Medical device shortage: FX Oxygenator with Integrated Arterial Filter and Hardshell Venous Reservoir
The FX Oxygenator with Integrated Arterial Filter and Hardshell Venous Reservoir 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 2023-03-21 Footnote 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
FX Oxygenator with Integrated Arterial Filter and Hardshell Venous Reservoir
Other names (for example trade name), if applicable
n/a
Package description (for example, packaging formats, sizes, quantities)
4 per box
Class of medical device (I, II, III or IV), if known
Class III
Device identifier(s) (for example, serial number, catalogue number, part number, model number or unique device identifier)
3CX*FX15RW30C
3CX*FX15RE30C
3CX*FX15RW40C
3CX*FX15RE40C
3CX*FX25REC
3CX*FX25RWC
Medical device licence number (for Class II, III and IV), if applicable
93775
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
No
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
n/a
Manufacturer’s name
Terumo Cardiovascular Systems Corporation
Manufacturer’s mailing address
125 Blue Ball Road
Elkton, MD
US
21921
Reason for shortage
Disruption of the manufacturing of a medical device
Footnotes
- 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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