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Health product recall

Cardiac Catheterization Pack and By-pass Pack (2014-01-29)

Starting date:
January 29, 2014
Posting date:
March 20, 2014
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-38455

Recalled Products

A. Cardiac Catheterization pack
B. By-pass pack

Reason

Carefusion’s  SmartSite needle free connector component 2000e found in these kits are under recall. The SmartSite connector may unintentionally disconnect from a female luer during infusion. An inability to disconnect may require replacement of a line.

Affected products

 A. Cardiac Catheterization pack

Lot or serial number

SAN30CLJTA

Model or catalog number

161459
164743
168632
 

Companies
Manufacturer
Cardinal Health Medical Segment
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES

B. By-pass pack

Lot or serial number

PC30CASC1
PC30CASCA
PC30CASCB

Model or catalog number

116164
163047
171083
93266

Companies
Manufacturer
Cardinal Health Medical Segment
1500 Waukegan Road
Waukegan
60085
Illinois
UNITED STATES