Recalls / —
—#41905
Product
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short 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 050-779, Model # 1523211; Lot 050-779, Model # 1523215.
Why it was recalled
Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
Root cause (FDA determination)
Other
Action the firm took
FedEx packages were sent out to their customers 9/13/2005.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- The product is distributed directly to the firm''s sales representatives and direct accounts.
Timeline
- Recall initiated
- 2005-09-13
- Posted by FDA
- 2005-11-16
- Terminated
- 2006-10-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #41905. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.