Numed Inc. has recalled four units of the BIB Balloon in Balloon Dilatation Catheter (Model 420) due to a printing error on the device labels. The inner balloon inflation hub was incorrectly labeled as the outer balloon, and the outer balloon inflation hub was incorrectly labeled as the inner balloon. No incidents or injuries have been reported, but healthcare providers are advised to stop using these specific units immediately.
The swapped labels on the inflation hubs could cause a clinician to inflate the wrong balloon during a medical procedure. This labeling error poses a risk of procedural delays or potential injury to the patient during catheterization.
Catheter Product Code: BB005.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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