Freudenberg Medical, LLC: Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. Quantity: 12 units Lot/code info: Lot #0000369233/UDI: 00813307014133

UPC codes

00813307014133

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.