AEROSET System External Waste Pump
FDA device recall Z-0796-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
- Action taken
- Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 461 units
- Distribution
- Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia,
- Date initiated
- 2003-01-27
- Date posted
- 2003-05-09
- Date terminated
- 2004-04-07
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |