FDA Recall
Completed
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Recall: Z-0224-2025
·
Initiated March 13, 2023
Recall
- Recall Number
- Z-0224-2025
- Event Number
- 95428
- Firm
- Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom
- FEI Number
- 3006073153
- Product Code
- DTQ
- Status
- Completed
- Root Cause
- Component design/selection
- Initiated
- March 13, 2023
- Posted
- October 24, 2024
Description
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Reason
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Action
All potentially affected product was identified. The firm corrected all products between 03/13/2024 and 08/07/2024 during service visits.
Distribution
US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.
Quantity
172 units