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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Recall Number Z-1862-2013
Classification Class II
Code Info Product code: BC8524A; All lots manufactured after March 1, 2011
Product Distributed Qty 625
Reason For Recall Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

Event Detail

Event Id 64625
Product Type Devices
Status Ongoing
Recalling Firm Acclarent, Inc.
City Menlo Park
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.