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Health product recall

Paxman scalp cooling caps and accessories (2016-02-26)

Starting date:
February 26, 2016
Posting date:
March 17, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57490

Affected Products

A. paxman scalp silicone cooling cap

B. paxman scalp neoprene cooling cap

C. paxman neoprene tail covers and hose sleeves

 

Reason

Labelling of the devices are required to meet section 21, section 22, and section 32 of the Medical Devices Regulations.

Affected products

A. paxman scalp silicone cooling cap

 

Lot or serial number

All Lots

Model or catalog number

100-08-45

100-08-46

100-08-47

100-08-48

100-08-49

Companies
Manufacturer

PAXMAN COOLERS LIMITED

INTERNATIONAL HOUSE, PENISTONE RD

FENAY BRIDGE, HUDDERSFIELD



B. paxman scalp neoprene cooling cap

 

Lot or serial number

All Lots

Model or catalog number

500-08-88

500-08-89

500-08-90

500-08-91

500-08-92

Companies
Manufacturer

PAXMAN COOLERS LIMITED

INTERNATIONAL HOUSE, PENISTONE RD

FENAY BRIDGE, HUDDERSFIELD



C. paxman neoprene tail covers and hose sleeves

Lot or serial number

All Lots

Model or catalog number

500-08-86

500-08-86A

500-08-87

500-08-87B

Companies
Manufacturer

PAXMAN COOLERS LIMITED

INTERNATIONAL HOUSE, PENISTONE RD

FENAY BRIDGE, HUDDERSFIELD