Ecc. O. Integrated Mini Bypass System with Preconnected Tubing, Primo2x Oxygenator w Integrated Hardshell Venous Reservoir, Synthesis Oxygenator w Heat Exchanger Arterial Filter and Venous Reservoir, D903 Avant 2 Adult Hollow Fiber Oxygenator, Synergy Adult Integrated Mini Bypass System, D905 EOS Pediatric Hollow Fiber Oxygenator, D905 Module Pediatric Hollow Fiber Oxygenator, Apex HP Phisio Smart Hollow Fiber Membrane Oxygenator , I) D903 Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator, Primo2X Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator, Synthesis Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator, Synthesis Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator, D901 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator, D902 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator and D905 EOS Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator (December 08, 2011)

Starting date:

December 08, 2011

Posting date:

January 09, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69647

• Reason
• Affected products

Reason

Sorin Group Italia has received customer complaints reporting a leak between the blood and water compartments of the heat exchanger used in the referenced oxygenators. The occurrence rate has been extremely low (less than 0.002%) and to date there have been no reports of any associated patient injuries.

Affected products