Reported Nov 13, 2013 · Terminated
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Helix Medical LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Helix Medical LLC · 1110 Mark Ave · Carpinteria, CA · 93013-2918
Is this the product you have?
- Blom-Singer
- Adjustable Tracheostoma Valve II ModelsBE8025H and BE8025H-R3
- Lot codes and dates
- LOTS
10577601057919 and 1059222
- LOTS
- Amount recalled
- 47 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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