Recall Z-0431-06 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
| Date | Jan 24, 2006 (initiated Nov 28, 2005) |
| Status | Terminated |
| Reason | Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6) |
| Root cause | Other |
| Action | Customers were notified of the recall on 11/28/2005 via letter sent by UPS. |
| Quantity | 536 units |
| Distribution | The device is distributed nationwide to hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 Integra Neurosciences, Sep 13, 2002 |