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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