Helix Medical Recalls Blom-Singer Adjustable Tracheostoma Valve II Due to Missing Component
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates the product is not likely to cause adverse health consequences. The issue is a packaging defect resulting in a non-functional device, with no reported injuries or illnesses.
Plain-English summary
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II), specifically models BE8025H and BE8025H-R3. The recall is being conducted because the body component of the device is missing from the packaging. Without this specific component, the ATSV II Valve product cannot be used as intended.
The affected units are identified by lot numbers 1057760, 1057919, and 1059222. These devices were distributed nationwide in the United States as well as in Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Consumers who possess these specific units should stop using the device immediately, as it is not functional without the missing body component. Users should contact Helix Medical LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- Manufacturer
- Helix Medical LLC
- Affected units
- 47
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- LOTS: 1057760
- 1057919 and 1059222
Distribution
Distributed nationwide across the United States.
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