Aeris Balloon Dilation Catheter recall: Labeling Error
Aeris Balloon Dilation Catheter
Why was Aeris Balloon Dilation Catheter recalled?
Devices were mislabeled.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
- Product
- Aeris Balloon Dilation Catheter
- Recalling firm
- Bryan Medical Inc
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of GA, NY, & PA.
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)