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MEPILEX BORDER 7.5 X 7.5CM (2016-01-15)
- Starting date:
- January 15, 2016
- Posting date:
- February 12, 2016
- 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-57110
Affected Products
A. MEPILEX BORDER 7.5 X 7.5CM
Reason
Molnlycke Health Care Canada is reporting a label defect in their product Mepilex Border 7.5 cm x 7.5 cm. The defect is that an incorrect pictogram on the back of retail package identifies the non-critical dimensions for the inner wound pad to be 6.5 cm x 6.5 cm when the actual dimensions are 4.5 cm x 4.5 cm. Internal investigations have revealed there are no other defects with this product. The identified defect has no impact on product integrity, sterility, safety or efficacy.
Affected products
A. MEPILEX BORDER 7.5 X 7.5CM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
295200
Companies
- Manufacturer
-
Molnlycke Health Care AB
GAMLESTADSVAGEN 3C
GOTEBORG
SWEDEN