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CADD ADMINISTRATION SETS WITH FLOW STOP (2016-05-05)
- Starting date:
- May 5, 2016
- Posting date:
- May 20, 2016
- 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-58502
Affected products
A. CADD ADMINISTRATION SETS WITH FLOW STOP
Reason
Smiths is notifying users of CADD Administration Sets with flow stop that these listed sets may affect flow rate when used with a variety of CADD ambulatory infusion pumps. This may result in under-delivery of medication by an average additional 5.2% beyond the labeled system delivery accuracy claim of +/- 6.0%. If drug under-delivery occurs, patients may not receive their full volume of medicinal product in the prescribed timeframe.
Affected products
A. CADD ADMINISTRATION SETS WITH FLOW STOP
Lot or serial number
All lots with EXPIRY ON/BEFORE MAR 2021
Model or catalog number
21-7321-01
21-7321-24
21-7322-01
21-7322-24
21-7323-24
21-7324-01
21-7324-24
21-7333-24
21-7336-01
21-7336-24
21-7339-01
21-7339-24
21-7359-01
21-7359-24
21-7383-01
21-7383-24
21-7390-01
21-7390-24
21-7391-01
21-7391-24
21-7394-01
21-7394-24
21-7395-24
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul
55112
Minnesota
UNITED STATES