Blom-Singer Adjustable Tracheostoma Valve II recall
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Why was Blom-Singer Adjustable Tracheostoma Valve II 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOTS: 1057760, 1057919 and 1059222
- Product
- Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- Recalling firm
- Helix Medical LLC
- Quantity
- 47 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
- Recall date
- November 13, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)