FDAFDA · Food and drugs·Recall number Z-0128-2014
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Published November 13, 2013 · Recall initiated: October 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Helix Medical LLC
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
- Lot
- LOTS: 1057760, 1057919 and 1059222
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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