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BURN RELIEF BURN PRODUCTS (2015-09-30)
- Starting date:
- September 30, 2015
- 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-55658
Affected Products
A. BURN RELIEF - BURN KIT
B. BURN RELIEF - BURN WRAP
C. BURN RELIEF - BODY TOWEL
D. BURN RELIEF - FIRE BLANKET
Reason
Fabricator could not provide testing records to demonstrate continued validity of the sterilization dose for the burn relief products.
Affected products
A. BURN RELIEF - BURN KIT
Lot or serial number
1149
1150
1151
1152
5183
5210
Model or catalog number
06BK1200
06BK1201
Companies
- Manufacturer
-
O-Two Medical Technologies Inc.
7575 Kimbel Street
Mississauga
L5S 1C8
Ontario
CANADA
B. BURN RELIEF - BURN WRAP
Lot or serial number
Not applicable
Model or catalog number
06BK1221
06BK1222
Companies
- Manufacturer
-
O-Two Medical Technologies Inc.
7575 Kimbel Street
Mississauga
L5S 1C8
Ontario
CANADA
C. BURN RELIEF - BODY TOWEL
Lot or serial number
Not applicable
Model or catalog number
06BK1231
Companies
- Manufacturer
-
O-Two Medical Technologies Inc.
7575 Kimbel Street
Mississauga
L5S 1C8
Ontario
CANADA
D. BURN RELIEF - FIRE BLANKET
Lot or serial number
Not applicable
Model or catalog number
06BK1232
Companies
- Manufacturer
-
O-Two Medical Technologies Inc.
7575 Kimbel Street
Mississauga
L5S 1C8
Ontario
CANADA