Reason
Following
observation of variable burst pressure performance of Polyisoprene
Condoms manufactured during 2017, Reckitt Benckiser Canada conducted an
internal investigation and identified that a specific batch (1000356816)
of DUREX RealFeel® 20 ct condoms distributed in Canada is not expected
to meet the registered burst pressure specification at end of
shelf-life. As a cautionary measure, Reckitt Benckiser Health (Canada)
Inc. is initiating a consumer level recall.
- Starting date:
- December 26, 2018
- Posting date:
- December 27, 2018
- 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-68718
Affected products
DUREX RealFeel 20 ct condoms
Reason
Following observation of variable burst pressure performance of Polyisoprene Condoms manufactured during 2017, RB conducted an internal investigation and identified that a specific batch (1000356816) of DUREX RealFeel® 20 ct condoms distributed in Canada is not expected to meet the registered burst pressure specification at end of shelf-life. As a cautionary measure, RB Health (Canada) Inc. is initiating a consumer level recall.
Affected products
DUREX RealFeel 20 ct condoms
Lot or serial number
1000356816
Model or catalog number
97177 (20 COUNT)
Companies
- Manufacturer
- Reckitt Benckiser (Canada) Inc
1680 Tech Avenue, Unit 2
Mississauga, Ontario
L4W 5S9
CANADA
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