Home / Recalls / Helix Medical LLC / Z-0128-2014

Z-0128-2014 Class III Terminated

Recalled by Helix Medical LLC — Carpinteria, CA

Recall Details

Product Type: Devices
Report Date: November 13, 2013
Initiation Date: October 1, 2013
Termination Date: January 21, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 47 units

Product Description

Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

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.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.

Code Information

LOTS: 1057760, 1057919 and 1059222