Oxygenator and other products

Starting date:

December 8, 2011

Posting date:

January 9, 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-15131

• Reason
• Affected products

Recalled products

1. Ecc. O. Integrated Mini Bypass System with Preconnected Tubing
2. Primo2x Oxygenator w Intergrated Hardshell Venous Reservoir
3. Synthesis Oxygenator w Heat Exchanger Arterial Filter and Venous Reservoir
4. D903 Avant 2 Adult Hollow Fiber Oxygenator
5. Synergy Adult Intergrated Mini Bypass System
6. D905 EOS Pediatric Hollow Fiber Oxygenator
7. D905 Module Pediatric Hollow Fiber Oxygenator
8. Apex HP Phisio Smart Hollow Fiber Membrane Oxygenator
9. D903 Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator
10. Primo2X Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator
11. Synthesis Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w Oxygenator
12. Synthesis Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator
13. D901 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator
14. D902 Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator
15. D905 EOS Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

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