This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Bubble CPAP System, Components and Nasal Prong (2014-04-11)
- Starting date:
- April 11, 2014
- Posting date:
- May 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39317
Recalled Products
A. Bubble CPAP System
B. Bubble CPAP System - Components
C. Nasal Prong
Reason
FPH (Fisher and Paykel Healthcare) introduced a new version of Nasal CPAP prongs in 2013. Since the release of this new version, FPH has received reports of the affected prongs detaching from the nasal tubing use, especially in the presence of mucous and/or moisture. The nasal tubing is not affected by this recall.
Affected products
A. Bubble CPAP System
Lot or serial number
131007-140325
Model or catalog number
BC461-SK
BC471-SK
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND
B. Bubble CPAP System - Components
Lot or serial number
131007-140325
Model or catalog number
BC490-SK
BC491-SK
BC492-SK
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND
C. Nasal Prong
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND