Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circula
FDA device recall Z-0205-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- Local pump controls including start/stop button, select button and manual button may not function.
- Action taken
- Consignees were notified by recall letter dated 7/18/08 and were provided with revised operating instructions telling them to revert to the central control module should these problems occur.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 626
- Distribution
- Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi
- Date initiated
- 2008-07-18
- Date posted
- 2008-10-31
- Date terminated
- 2009-07-07
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
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 |