Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
FDA device recall Z-0823-06 · posted 2006-04-29 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
- Action taken
- Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 151 units
- Distribution
- Nationwide
- Date initiated
- 2005-12-21
- Date posted
- 2006-04-29
- Date terminated
- 2008-03-12
- Location
- Braintree, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM (K014083) | Haemonetics Corp. | 2002-01-08 |