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Health product recall

APC II Victory Series Buccal Tubes (2015-10-05)

Starting date:
October 5, 2015
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-56174

Affected Products

APC II Victory Series Buccal Tubes

Reason

The inner label of the buccal tube itself shows a notation (palmer notation) indicating that the contents are a lower right buccal tube, when in fact the contents are a lower left buccal tube. The part number is correct on the inner label. The part number and palmer notation on the outer label (of a 5-pack box) are correct.

Affected products

APC II Victory Series Buccal Tubes

Lot or serial number
  • GQ9AE
  • GR1MA
  • GR2LA
  • GR3FB
  • GR4SP
Model or catalog number
  • 3066-5033
  • 3067-6363
  • 3067-9013
  • 3067-9773
Companies
Manufacturer

3M UNITEK CORPORATION

DBA 3M UNITEK ORTHODONTIC PRODUCTS

2724 SOUTH PECK ROAD

MONROVIA

91016

California

UNITED STATES