Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
FDA device recall Z-0141-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
- Action taken
- FedEx packages were sent out to their customers 9/13/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFL
- Quantity affected
- 24 (four 1 packs)(four 5 packs)
- Distribution
- The product is distributed directly to the firm''s sales representatives and direct accounts.
- Date initiated
- 2005-09-13
- Date posted
- 2005-11-16
- Date terminated
- 2006-10-03
- 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 |