Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
FDA device recall Z-1002-2007 · posted 2007-07-07 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
- Action taken
- As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 728 pumps of all models
- Distribution
- Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia,
- Date initiated
- 2004-07-01
- Date posted
- 2007-07-07
- Date terminated
- 2007-12-12
- 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 |
|---|---|---|
| SARNS 9000 UNIVERSAL ROLLER PUMP (K953904) | 3M Health Care, Ltd. | 1996-04-19 |
| SARNS 8000 MODULAR PERFUSION SYSTEM (K915183) | 3M Health Care, Sarns | 1992-07-08 |