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Health product recall

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