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Health product recall

Sarns Soft-Flow Aortic Cannulae

Starting date:
November 30, 2012
Posting date:
December 24, 2012
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-25909

Recalled Products

  1. Sarns Soft-Flow Aortic Cannulae, Straight Tip, Luer Port
  2. Sarns Soft-Flow Aortic Cannulua, Angled Tip, Luer Port, Wire-Reinforced

Reason

During in-house inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of excess plastic material, or flash, on the tip of the Sarns Soft-Flow aortic cannula. The flash has the potential to detach.

Affected products

A. Sarns Soft-Flow Aortic Cannulae, Straight Tip, Luer Port

Lot or serial number

0581138

Model or catalog number

5845

Companies
Manufacturer
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES

B. Sarns Soft-Flow Aortic Cannulua, Angled Tip, Luer Port, Wire-Reinforced

Lot or serial number

0570466

Model or catalog number

5762

Companies
Manufacturer
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES