Blom-Singer voice prosthesis recalled over mislabeled flange boxes
Freudenberg Medical is recalling 12 units of the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF 1610-LEF), from lot 0000369233. Some boxes labeled as the Large Esophageal Flange contain the Large Esophageal and Tracheal Flange, and the reverse. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check the REF number and lot number on the box before using this device.
- Confirm the flange type inside the box with your doctor or care team before use.
- Contact Freudenberg Medical or your healthcare provider about returning or replacing an affected unit.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 12 units
- Illnesses reported
- None reported
- Manufactured in
- 1110 Mark Ave, Carpinteria, CA, United States
- Classification
- Class II
- Recall number
- Z-2909-2026
In the FDA's words
- Description
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF 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 #0000369233/UDI: 00813307014133 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: 12 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-LEF (this page)Z-2909-2026 · 12 units
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LFZ-2910-2026 · 40 units