Aura40 Straight Laryngeal Mask, White Sensor ECG Electrodes, Center Snap, Solid Gel, Cannutherm Kit, Ambu Open Cuff Silicone Face Mask (2019-10-10)
- Starting date:
- October 10, 2019
- Posting date:
- October 18, 2019
- 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-71317
Last updated: 2019-10-18
Affected Products
A. Aura40 Straight Laryngeal Mask
B. White Sensor ECG Electrodes, Center Snap, Solid Gel
C. Cannutherm Kit
D. Ambu Open Cuff Silicone Face Mask
Reason
Previously licensed medical devices were shipped to Canada after medical device licences were cancelled due to the manufacturer's decision to not transfer from ISO 13485 to MDSAP certification.
Affected products
A. Aura40 Straight Laryngeal Mask
Lot or serial number
MO0611G40041
MO0704G10026
MO0704G10027
MO0705G40011
MO0705G40018
MO0705G40019
MO0707G40047
MO0708G40084
MO0708G40085
Model or catalog number
340 100 000
340 300 000
340 400 000
340 500 000
342 150 000
Companies
- Manufacturer
-
Ambu A/S
BALTORPBAKKEN 13
BALLERUP
2750
DENMARK
B. White Sensor ECG Electrodes, Center Snap, Solid Gel
Lot or serial number
40718S5M4A
46518S5M4A
Model or catalog number
WS-00-S/4
Companies
- Manufacturer
-
Ambu A/S
BALTORPBAKKEN 13
BALLERUP
2750
DENMARK
C. Cannutherm Kit
Lot or serial number
J333093
J335123
Model or catalog number
814310-100
Companies
- Manufacturer
-
Ambu A/S
BALTORPBAKKEN 13
BALLERUP
2750
DENMARK
D. Ambu Open Cuff Silicone Face Mask
Lot or serial number
180618
181105
181119
181224
190325
Model or catalog number
251001
251002
251005
251006
Companies
- Manufacturer
-
Ambu A/S
BALTORPBAKKEN 13
BALLERUP
2750
DENMARK