United StatesBlom-Singer Classic Indwelling Voice Prosthesis (16Fr/10 mm) REF 1610-LEF and REF 1610-LF, lots #0000369233 (UDI 00813307014133) and #0000369205 (UDI 00813307014232), are affected. The recall is for incorrect labeling: boxes labeled as Large Esophageal Flange contain a Large Esophageal and Tracheal Flange, and boxes labeled as Large Esophageal and Tracheal Flange contain a Large Esophageal Flange; units were distributed nationwide in the US (IN, OH, AZ, WA, FL, MO, KY, NY) and to the UK and France.
What's being recalled
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Recalling firm: Freudenberg Medical, LLC, Carpinteria, CA, United States.
How to identify it
Lot #0000369233/UDI: 00813307014133 Lot #0000369205/UDI: 00813307014232
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)