Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA device recall Z-0924-2007 · posted 2007-06-30 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.
- Action taken
- The firm is visiting consignees and making corrections as complaints are received. These corrections, to date, have been made between 04/04 and 09/06. The firm will correct other units as complaints are received and issued a Device Correction Letter dated 6/6 /07 notifying all users of the problem and appropriate responses should it occur.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 525 total for both models
- Distribution
- Worldwide: USA, Belgium, Canada, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore and United Arab Emirates.
- Date initiated
- 2004-04-01
- Date posted
- 2007-06-30
- Date terminated
- 2008-06-11
- 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 |