BIB Balloon in Balloon Dilatation Catheter labeling error recalled
Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model Number 420 due to incorrect labeling of balloon inflation hubs. The inner and outer balloon labels are swapped, which could lead to improper device use.
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: This is an FDA Class II recall involving labeling that could lead to improper device use. However, no hospitalization reports or confirmed injuries are stated in the source, and the error is a labeling/operational issue rather than a product-integrity hazard. This meets the criteria for Moderate severity.
Plain-English summary
Numed Inc is recalling the BIB Balloon in Balloon Dilatation Catheter, Model Number 420, distributed in the United States to Pennsylvania. The device's balloon extension lumens are labeled incorrectly—specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
This labeling error could result in incorrect inflation of the intended balloon during medical procedures. The recall affects 4 units of the device. Affected lot numbers are BIB-16972 (expiration date 11/30/2028) and BIB-16972-1 (expiration date 12/31/2028), with UDI-DI 04046964899768.
Healthcare providers who have received this device should contact Numed Inc immediately to verify whether their inventory is affected and arrange for replacement units with correct labeling. Any device from the recalled lots should not be used until proper verification and replacement are confirmed.
The recalled product
- Product
- BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
- Manufacturer
- Numed Inc
- Hazard
- labeling-error
- incorrect-use
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)
- BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
Distribution
Distribution scope not specified by the agency.
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