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ARCTICGEL PADS (FOR ARCTIC SUN 2000 & 5000 MODELS) (2017-11-07)
- Starting date:
- November 7, 2017
- Posting date:
- November 22, 2017
- 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-65212
Affected products
A. ARCTICGEL PADS (FOR ARCTIC SUN 2000 MODEL)
B. ARCTICGEL PADS (FOR ARCTIC SUN 5000 MODEL)
Reason
Bard has received complaints reporting that the hydrogel peeled away from pads during the removal of the release liner. The issue affects specific lots of ARCTICGEL pad kits and may result in the insufficient adhesion of the hydrogel to the pad. Product return is not required as part of the recall notification.
Affected products
A. ARCTICGEL PADS (FOR ARCTIC SUN 2000 MODEL)
Lot or serial number
NGAW3055
NGAW4510
NGAZ2312
NGAZ3417
NGBN3536
NGBP1302
NGBQ1040
Model or catalog number
317-00
317-05
317-07
Companies
- Manufacturer
-
Medivance, Inc.
321 South Taylor avenue, Suite 200
Louisville
80027
Colorado
UNITED STATES
B. ARCTICGEL PADS (FOR ARCTIC SUN 5000 MODEL)
Lot or serial number
NGAW3055
NGAW4510
NGAZ2312
NGAZ3417
NGBN3536
NGBP1302
NGBQ1040
NGBQ2024
Model or catalog number
317-00
317-03
317-05
317-07
Companies
- Manufacturer
-
Medivance, Inc.
321 South Taylor avenue, Suite 200
Louisville
80027
Colorado
UNITED STATES