Friday, December 28, 2018

Reckitt Benckiser Canada Recalls DUREX RealFeel 20 ct condoms

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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