Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis Recall
Freudenberg Medical, LLC is recalling the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF: 1610-LEF) due to incorrect labeling. The Large Esophageal Flange box contains a Large Esophageal and Tracheal Flange, and the Large Esophageal and Tracheal Flange box contains a Large Esophageal Flange. Approximately 40 units were shipped nationwide in the US (IN, OH, AZ, WA, FL, MO, KY, IN, NY) and to GBR and FRA; Recall Number Lot #0000369205 / UDI: 00813307014232 is listed.
| Brand | Freudenberg Medical, LLC |
|---|---|
| Product | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF |
| Reason | 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. |
| Severity | moderate |
| Units affected | 12 |
| Distribution | US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use the recalled Blom-Singer Classic Indwelling Voice Prosthesis (REF: 1610-LEF) and set affected units aside.
- Contact Freudenberg Medical, LLC or your supplier for instructions on return, replacement, or safety guidance related to this recall.
- If you have questions about which device you possess, provide the lot number (Lot #0000369205) and UDI (00813307014232) when contacting the manufacturer or FDA.
- Monitor for any symptoms or issues and report safety concerns to the manufacturer or FDA as appropriate.
How to identify the recalled item
| Lot / date codes | Lot #0000369205/UDI: 00813307014232 |
|---|---|
| Lot / date codes | Lot #0000369233/UDI: 00813307014133 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.