Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOTS: 1057760, 1057919 and 1059222
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Helix Medical LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Product Codes/Lot Numbers:
LOTS: 1057760, 1057919 and 1059222
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0128-2014
Related Recalls
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.