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CALCIUM ALGINATE TIPPED APPLICATOR (2014-03-26)
- Starting date:
- March 26, 2014
- Posting date:
- May 6, 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-53241
Recalled Products
A. CALCIUM ALGINATE FIBER TIPPED WOOD APPLICATOR
B. CALCIUM ALGINATE FIBER TIPPED ALUMINUM APPLICATOR
C. CALCIUM ALGINATE FIBER TIPPED PLASTIC APPLICATOR
Reason
Five customer complaints reported the presence of an organism in the product identified above. The product is labeled as sterile. The presence of an organism has been confirmed by an independent laboratory working on behalf of our supplier
Affected products
A. CALCIUM ALGINATE FIBER TIPPED WOOD APPLICATOR
Lot or serial number
61513
61866
62546
8710
Model or catalog number
14-959-81
14-959-82
Companies
- Manufacturer
-
Thermo Fisher Healthcare
9999 Veterans Memorial Drive
Houston
77038
Texas
UNITED STATES
B. CALCIUM ALGINATE FIBER TIPPED ALUMINUM APPLICATOR
Lot or serial number
60151
60752
61324
61513
61933
62195
62768
63055
63224
Model or catalog number
14-959-77, 14-959-78
Companies
- Manufacturer
-
Thermo Fisher Healthcare
9999 Veterans Memorial Drive
Houston
77038
Texas
UNITED STATES
C. CALCIUM ALGINATE FIBER TIPPED PLASTIC APPLICATOR
Lot or serial number
60752
62195
Model or catalog number
14-959-79
Companies
- Manufacturer
-
Thermo Fisher Healthcare
9999 Veterans Memorial Drive
Houston
77038
Texas
UNITED STATES