Recall Z-0141-06 ยท LFL Instrument, Ultrasonic Surgical
Integra LifeSciences Corp.
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
| Date | Nov 16, 2005 (initiated Sep 13, 2005) |
| Status | Terminated |
| Reason | Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. |
| Root cause | Other |
| Action | FedEx packages were sent out to their customers 9/13/2005. |
| Quantity | 24 (four 1 packs)(four 5 packs) |
| Distribution | The product is distributed directly to the firm''s sales representatives and direct accounts. |
| 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 |