Recalls / —
—#96789
Product
2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
- FDA product code
- DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K060053
- Affected lot / code info
- Serial Numbers: 50E50153, 50E0154, 50K00332 to 50K00685.
Why it was recalled
Touch screen may become unresponsive, inhibiting user input.
Root cause (FDA determination)
Device Design
Action the firm took
All affected US customers and distributors were notified by certified mail on Nov 12, 2010 via a Field Correction letter. They were told that they would be contacted by Sorin to arrange an appointment to inspect and replace affected touch screens on site. They were told that they could safely continue using their S5 systems in accordance with the Operator's Manual and previously supplied instructions until the inspection and necessary replacement had been completed. A customer response form was also included for completion and return to the firm. Customers can contact the firm if they have any questions.
Recalling firm
- Firm
- Sorin Group USA, Inc.
- Address
- 14401 W 65th Way, Arvada, Colorado 80004
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2010-11-12
- Posted by FDA
- 2011-01-26
- Terminated
- 2012-07-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #96789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.