Health product recall

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