Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling correction to clarify instructions and add warnings, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary measures.
Plain-English summary
Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 5 x 24 mm, with a syringe volume of 6-8 cc. The recall involves 1,920 units of the device, which is used for the dilation of the airway tree. The product code is BC0524A, and the recall includes all lots manufactured after March 1, 2011.
The recall is a labeling correction intended to include additional language and warnings, as well as to clarify some instructional steps. The agency classification for this recall is Class II.
The affected products were distributed worldwide, including the United States (nationwide), Belgium, Canada, and Saudi Arabia. Users of the device should refer to the updated labeling for the corrected instructions and warnings.
The recalled product
- Product
- Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Airway Dilation
- Hazard
- Affected units
- 1,920
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)
- Product code: BC0524A
- All lots manufactured after March 1
- 2011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Acclarent, Inc. 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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