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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
- 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