Health product recall

DUREX RealFeel 20 ct condoms (2018-12-26)

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

A similar recall was initiated for DUREX Real Feel Extra Lubricated 10ct condoms on July 30, 2018.

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