Helix Medical Recalls Blom-Singer Occluder for Invalid Expiration Date
Helix Medical LLC is recalling the Blom-Singer indwelling TEP Occluder due to an invalid expiration date. The recall covers devices distributed in the US and UK.
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 is unlikely to cause adverse health consequences. The issue is an administrative labeling error (invalid expiration date) rather than a physical defect or contamination.
Plain-English summary
Helix Medical LLC is recalling the Blom-Singer indwelling TEP Occluder, a non-valved silicone prosthesis used to maintain tracheoesophageal punctures following total laryngectomy. The recall is being conducted because the affected devices have an invalid expiration date.
The recall involves 2 devices from Lot #1008419. These products were distributed worldwide, including nationwide in the United States (specifically noting Ohio) and in the United Kingdom.
Consumers and healthcare providers should stop using the affected devices and contact Helix Medical LLC for further instructions.
The recalled product
- Product
- BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The…
- Manufacturer
- Helix Medical LLC
- Hazard
- Affected units
- 2
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 (1)
- Lot#1008419
Distribution
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