Blom-Singer voice prosthesis recalled over mislabeled flanges
Freudenberg Medical is recalling one lot (0000369205) of the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF 1610-LF). The boxes are mislabeled: some boxes marked Large Esophageal Flange contain a Large Esophageal and Tracheal Flange, and the reverse is also true. About 40 units were distributed in several U.S. states and in the UK and France, and no injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the lot number and flange type inside any box before using this device.
- Do not use units from lot 0000369205 until the flange type has been verified.
- Contact Freudenberg Medical or your supplier for instructions on return or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 40 units
- Illnesses reported
- None reported
- Manufactured in
- 1110 Mark Ave, Carpinteria, CA, United States
- Classification
- Class II
- Recall number
- Z-2910-2026
In the FDA's words
- Description
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange. Lot #0000369205/UDI: 00813307014232 Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. Affected quantity: 40 units
- Hazard
- Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
2 products in this recall
Blom-Singer Classic voice prostheses recalled for mislabeling
Freudenberg Medical is recalling two Blom-Singer Classic Indwelling Voice Prosthesis products (16Fr/10 mm, REF 1610-LEF and 1610-LF) because the boxes are labeled incorrectly. The box labeled for one product holds the other, so the product inside may not match the label. The recall covers 52 units and was distributed nationwide in the US and to the UK and France. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFZ-2909-2026 · 12 units
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF (this page)Z-2910-2026 · 40 units