ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
FDA device recall Z-2822-2015 · posted 2015-09-30 · Terminated
Recall details
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Reason for recall
- There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
- Action taken
- The firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MUU
- Quantity affected
- 168, ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-06-12
- Date posted
- 2015-09-30
- Date terminated
- 2016-05-23
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROAIRE SURGICAL INSTRUMENTS LLC (K113128) | Microaire Surgical Instruments, LLC | 2012-08-17 |