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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. Product code: BC0524A; All lots manufactured after March 1, 2011 Class II 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. 1920 Z-1860-2013
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. Product code: BC0724A; All lots manufactured after March 1, 2011 Class II 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. 2366 Z-1861-2013
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC8524A; All lots manufactured after March 1, 2011 Class II 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. 625 Z-1862-2013
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1040A; All lots manufactured after March 1, 2011 Class II 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. 2703 Z-1863-2013
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1240A; All lots manufactured after March 1, 2011 Class II 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. 1217 Z-1864-2013
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1440A; All lots manufactured after March 1, 2011 Class II 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. 3324 Z-1865-2013
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree. Product code: BC1640A; All lots manufactured after March 1, 2011 Class II 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. 2175 Z-1866-2013
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