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

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  Reason
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  Affected products

 

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