Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use
FDA device recall Z-1964-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
- Action taken
- Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL-SAFETY ADVISORY" letter dated June 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 992 Units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indones
- Date initiated
- 2012-06-22
- Date posted
- 2012-07-09
- Date terminated
- 2013-02-19
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947) | Terumo Cardiovascular Systems Corp. | 2003-03-20 |