Blom-Singer Voice Prosthesis Boxes Mislabeled with Wrong Flange Type
Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls are typically scored at 4 (Severe) when there is potential for temporary or medically reversible adverse health consequences, which applies here due to the mislabeling of medical device flange types.
Plain-English summary
Freudenberg Medical, LLC is recalling 12 units of the Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm (REF: 1610-LEF), due to 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.
The recalled devices were distributed nationwide in the United States to the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY, and internationally to GBR and FRA. The affected product is identified by Lot #0000369233 and UDI: 00813307014133.
Healthcare providers and distributors should check their inventory for the affected lot number and UDI. Any mismatched devices should be quarantined and returned to the manufacturer. Consumers or patients with questions should contact their healthcare provider or Freudenberg Medical customer service.
This is a Class II recall issued by the U.S. Food and Drug Administration, meaning the device could cause temporary or medically reversible adverse health consequences if used as labeled.
The recalled product
- Product
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Manufacturer
- Freudenberg Medical, LLC
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #0000369233/UDI: 00813307014133
Distribution
Part of a larger recall action
This product is one of 2 recalled by Freudenberg Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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