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Shandon Rapid Chrome Kwik -Diff Kit
- Starting date:
- March 22, 2017
- Posting date:
- April 21, 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-63062
Reason
The methylene blue, solution #3 in the Kwik-Diff kit was not methylene blue but crystal violet. During investigation, it was verified that the contract manufacturer had labeled the methylene blue solution #3 incorrectly in the kits.
Affected products
Shandon Rapid Chrome Kwik -Diff Kit
Lot or serial number
- 234
- 35
- 36
- S646
- S647
- s645
Model or catalog number
- 28613
- 286134
Companies
- Manufacturer
-
RICHARD-ALLAN SCIENTIFIC
SUBSIDIARY OF THERMO FISHER SCIENTIFIC
4481 CAMPUS DRIVE
Kalamazoo
49008
Michigan
UNITED STATES