Recalls / —
—#43267
Product
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
- FDA product code
- LFL — Instrument, Ultrasonic Surgical
- Device class
- Class U
- Medical specialty
- Unknown
- 510(k) numbers
- K021989
- Affected lot / code info
- Lot 050678 and Lot 050575.
Why it was recalled
Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
Root cause (FDA determination)
Other
Action the firm took
Customers were notified of the recall on 11/28/2005 via letter sent by UPS.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- The device is distributed nationwide to hospitals nationwide.
Timeline
- Recall initiated
- 2005-11-28
- Posted by FDA
- 2006-01-24
- Terminated
- 2007-02-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.