BIB Balloon in Balloon Dilatation Catheter Recall Due to Swapped Labels
Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model 420 due to incorrect labeling of balloon extension lumens. The inner and outer balloon inflation hubs are labeled backwards, creating risk of incorrect balloon inflation during procedures.
What this means for you
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: FDA Class II medical device recall with mislabeled critical functional components creating procedural risk. No reported injuries or illnesses. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' yielding a High severity score.
Plain-English summary
Numed Inc is recalling the BIB Balloon in Balloon Dilatation Catheter, Model 420. The balloon extension lumens contain incorrect labeling: the inner balloon inflation hub is labeled as the outer balloon, and the outer balloon inflation hub is labeled as the inner balloon.
The recall affects 4 units distributed to Pennsylvania. Affected devices are identified by Model Number 420, UDI-DI 04046964899768, with lot numbers BIB-16972 (expiration 11/30/2028) and BIB-16972-1 (expiration 12/31/2028).
This mislabeling could result in incorrect balloon inflation during medical procedures, as a healthcare provider may inflate the wrong balloon or apply incorrect pressure. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
- Manufacturer
- Numed Inc
- Category
- Medical Device
- Hazard
- mis-labeling
- incorrect-balloon-inflation
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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