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Terminated

Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10

FDA Recall Z-2425-2010 · Posted 2010-09-22

Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeHAO
Date Initiated2010-07-02
Date Terminated2012-05-29
Product Quantity338 units

Reason for Recall

Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.

Firm Action

All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.

Root Cause

Process design

Distribution Pattern

Nationwide, Canada, Taiwan and to Integra, Australia.

Official Source

View FDA Recall →

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

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