Class II
Medical Device Recall: BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc · April 21, 2025
Reason for Recall
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Distribution
US distribution to Pennsylvania.
Quantity Affected
4 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1754-2025
Status: terminated
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