TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
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Lot #0000369233/UDI: 00813307014133
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Company
- Freudenberg Medical, LLC
- Announced
- Recall began