Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
FDA Recall Z-0141-06 · Posted 2005-11-16
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeLFL
Date Initiated2005-09-13
Date Terminated2006-10-03
Product Quantity24 (four 1 packs)(four 5 packs)
Reason for Recall
Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
Firm Action
FedEx packages were sent out to their customers 9/13/2005.
Root Cause
Other
Distribution Pattern
The product is distributed directly to the firm''s sales representatives and direct accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.