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CPAP System
- Starting date:
- September 28, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16319
Recalled Products
- CPAP System - Circuits
- Aquavent CPAP Limb, Adult, Heated
- Aquavent Limb for Oxygen Therapy, Adult, Heated
- Aquavent Heated Breathing Circuits
- Aquavent Bipap Limb for Non-Invasive Ventilation
Reason
Armstrong Medical Ltd. is investigating the heater wire retainer (located in the heated limbs of adult corrugated heated ventilator and CPAP breathing circuits as a means to locate the heater wire in a fixed position).
The retainer is white or off-white in color and made from polymeric (plastics) material. If breakage of this component were to occur there could be a possible inhalation risk to the patient.
Affected products
A. CPAP System - Circuits
Lot or serial number
080310 to 310812
Model or catalog number
AMCPSI01052, AMCPUK01103
Companies
- Manufacturer
- Armstrong Medical Ltd.
B. Aquavent CPAP Limb, Adult, Heated
Lot or serial number
080310 to 310812
Model or catalog number
AMCP1409/003, AMCPUK01109
Companies
- Manufacturer
- Armstrong Medical Ltd.
C. Aquavent Limb for Oxygen Therapy, Adult, Heated
Lot or serial number
080310 to 310812
Model or catalog number
AMCP1409/004
Companies
- Manufacturer
- Armstrong Medical Ltd.
D. Aquavent Heated Breathing Circuits
Lot or serial number
080310 to 310812
Model or catalog number
AMVC1774/101, AMVC1774/102, AMVC1774/105, AMVC1774/106, AMVC1775/101, AMVC1775/102, AMVC1775/106, AMVC1775/108
Companies
- Manufacturer
- Armstrong Medical Ltd.
E. Aquavent Bipap Limb for Non-Invasive Ventilation
Lot or serial number
080310 to 310812
Model or catalog number
AMVC1792/130
Companies
- Manufacturer
- Armstrong Medical Ltd.