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Lifestyles Skyn Elite
- Starting date:
- August 22, 2017
- Posting date:
- September 11, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64478
Reason
On August 21, Ansell Healthcare Products LLC was advised that a retail customer had received the referenced product with English only (US) package labeling. The customer also received English/French (Canada) packages as well. The English only packaging was US market product labeling and not the carton labeling specific to Canada. The US package labeling is in English, does not contain French labeling, and does contain all required label elements required under ISO 4074 - natural rubber latex male condoms - requirement and test methods. This standard, to which Ansell attested compliance to under the original license, outlines the requirements for labeling.
Affected products
Lifestyles Skyn Elite
Lot or serial number
170719071C
Model or catalog number
7210
Companies
- Manufacturer
-
ANSELL HEALTHCARE PRODUCTS LLC
1635 INDUSTRIAL ROAD,
DOTHAN
36303
Alabama
UNITED STATES