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CADD Administration Set
- Starting date:
- March 17, 2017
- Posting date:
- April 13, 2017
- 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-62996
Reason
A drawing on the IFU incorrectly represents the actual filter size of the contents. Where the drawing should indicate that the package contains an administration set with a 0.2 micron filter, it is incorrectly illustrated as a 2.0 micron filter. The actual product in the package and the text based description on the IFU correctly conformed to the 0.2 micron filter specification for P/N 21-7339-24. It was the filter label on the drawing that was incorrect.
Affected products
CADD Administration Set
Lot or serial number
- 46x1001
- 46x817
- 46x828
- 46x829
- 46x831
- 46x896
- 46x897
- 46x899
- 46x990
Model or catalog number
21-7339-24
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul
55112
Minnesota
UNITED STATES