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Health product recall

Novopen 5 and Novopen Echo (2017-07-05)

Starting date:
July 5, 2017
Posting date:
July 18, 2017
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-64024

Affected Products

A. Novopen 5
B. Novopen Echo

Reason

Novo Nordisk A/S has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, for example certain cleaning agents. NovoPen Echo and NovoPen 5 are used for insulin treatment by people living with diabetes. NovoPen 4 and FlexTouch are not impacted.

Affected products

A. Novopen 5

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

0 59014 00520 4
0 59014 00522 8

Companies
Manufacturer
Novo Nordisk A/S Novo Nordisk (China) Pharmaceuticals Co. Ltd.
No 99 Nanhai Road
Tianjin
300457
CHINA

B. Novopen Echo

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

0 59014 00441 2
0 59014 00442 9

Companies
Manufacturer
Novo Nordisk A/S Novo Nordisk (China) Pharmaceuticals Co. Ltd.
No 99 Nanhai Road
Tianjin
300457
CHINA