Blom-Singer Voice Prosthesis Recalled Due to Incorrect Labeling
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error with no reported injuries or illnesses. Per the rubric, labeling errors without reported harm are classified as Moderate severity.
Plain-English summary
The U.S. Food and Drug Administration is recalling 40 units of the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF, manufactured by Freudenberg Medical, LLC. The recall affects lot #0000369205 with UDI 00813307014232.
The issue is incorrect labeling: boxes labeled for Large Esophageal Flange actually contain Large Esophageal and Tracheal Flange products, and boxes labeled for Large Esophageal and Tracheal Flange contain Large Esophageal Flange products.
The products were distributed nationwide in the United States (IN, OH, AZ, WA, FL, MO, KY, NY) and in the United Kingdom and France. Consumers should stop using the affected products and contact Freudenberg Medical for a replacement.
The recalled product
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- Manufacturer
- Freudenberg Medical, LLC
- Affected units
- 40
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 #0000369205/UDI: 00813307014232
Distribution
Part of a larger recall action
This product is one of 2 recalled by Freudenberg Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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