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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Recall Number Z-0128-2014
Classification Class III
Code Info LOTS: 1057760, 1057919 and 1059222
Product Distributed Qty 47 units
Reason For Recall InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.

Event Detail

Event Id 66423
Product Type Devices
Status Ongoing
Recalling Firm Helix Medical LLC
City Carpinteria
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.