Aeris Balloon Dilation Catheter Mislabeled — FDA Class II Recall
Bryan Medical Inc is recalling the Aeris Balloon Dilation Catheter distributed nationwide in Georgia, New York, and Pennsylvania due to mislabeling of the devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for mislabeled devices. While no illnesses or injuries have been reported, the mislabeling creates a risk that the devices could be used improperly, potentially causing adverse health consequences.
Plain-English summary
Bryan Medical Inc is recalling the Aeris Balloon Dilation Catheter, Model KG0930, Lot Number 1402309E. The devices were distributed nationwide in the states of Georgia, New York, and Pennsylvania. A total of 5 units were affected by this recall.
The devices have been recalled because they were mislabeled. The U.S. Food and Drug Administration has classified this as a Class II recall.
This recall affects the balloon dilation catheters bearing UDI +B472KG09301. Individuals who may have received or used these devices should contact Bryan Medical Inc for further information.
The recalled product
- Product
- Aeris Balloon Dilation Catheter
- Manufacturer
- Bryan Medical Inc
- Category
- Medical Device
- Hazard
- Affected units
- 5
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 (3)
- Model No: KG0930
- UDI: +B472KG09301
- Lot No. 1402309E.
Distribution
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