Medical device shortage: BiPAP Pro Bi-Flex
The BiPAP Pro Bi-Flex is currently reported as a medical device shortage through Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. Interim Order No. 2 repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19 (the previous interim order) made by the Minister on March 30, 2020. For a full list of shortages, refer to the list of medical device shortages.
Posted on 2021-09-01
Type of report
Actual medical device shortage
Name of medical device (including any component, accessory, consumable material or part that is in shortage, including the model name) if applicable
BiPAP Pro Bi-Flex
Other names (for example trade name), if applicable
n/a
Package description (for example, packaging formats, sizes, quantities)
1 per box
Class of medical device (I, II, III or IV), if known
Class II
Device identifier(s) (for example, serial number, catalogue number, part number, model number, or unique device identifier)
CA651; 661CA; CA651H; CA651HS; DS650HS; CA661HS; CA661NTS; CA661TS; CA661HBT; CA661NTBT; CA661TBT; CA651S; DS650S; CA661S; CA661BT
Medical device licence number (for Class II, III and IV), if applicable
80978
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
Respironics, Inc.
Manufacturer's mailing address
1001 Murry Ridge Lane
Murrysville, PA
US
15668
Reason for shortage
Device was subject to a recall
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