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Health product recall

Mentor Gel Sizers (2014-05-27)

Starting date:
May 27, 2014
Posting date:
June 12, 2014
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-40001

Recalled products

  1. Mentor Gel Sizers 

Reason

A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labeling (550cc) on a Mentor Gel Sizer. During the investigation, a second lot was identified as having a style discrepancy between the pad print moderate profile(MP) and all other product labeling moderate plus(M+).

Affected products

A. Mentor Gel Sizers (2014-05-27)

Lot or serial number
  • 6680501
  • 6749298
Model or catalog number
  • RSZ-2751
  • RSZ-5501
Companies
Manufacturer
Mentor Medical Systems
B.V., Zernikedreef 2
Leiden, Netherlands
2333 CL