Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.

FDA Recall Z-0431-06 · Posted 2006-01-24

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeLFL
Date Initiated2005-11-28
Date Terminated2007-02-26
Product Quantity536 units

Reason for Recall

Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)

Firm Action

Customers were notified of the recall on 11/28/2005 via letter sent by UPS.

Root Cause

Other

Distribution Pattern

The device is distributed nationwide to hospitals nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3Integra Neurosciences · 2002-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑