Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
USBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Recalling Firm: Freudenberg Medical, LLC
Reason for Recall / 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.
Product Description & Identification
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Affected Products
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Additional Source Details
| Field | Value |
|---|---|
| City | Carpinteria |
| State | CA |
| Event id | 99299 |
| Address 1 | 1110 Mark Ave |
| Code info | Lot #0000369205/UDI: 00813307014232 |
| Postal code | 93013-2918 |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 40 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260617 |
| Initial firm notification | Letter |
| Center classification date | 20260806 |
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Overview
- Recalling FirmFreudenberg Medical, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
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🚨 SAFETY ALERT: Freudenberg Medical, LLC - Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF Check if your household is affected: https://therecallfile.com/recalls/blom-singer-classic-indwelling-voice-prosthesis-16fr-10-mm-ref-1610-lf/FDA-Z-2910-2026
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