Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
FDA device recall Z-0431-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
- Action taken
- Customers were notified of the recall on 11/28/2005 via letter sent by UPS.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 536 units
- Distribution
- The device is distributed nationwide to hospitals nationwide.
- Date initiated
- 2005-11-28
- Date posted
- 2006-01-24
- Date terminated
- 2007-02-26
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (K021989) | Integra Neurosciences | 2002-09-13 |