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Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Recalled May 21, 2025 · FDA recall Z-1754-2025 · Numed
Hazard
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. · FDA Class II
Units
4 units
Sold at
US distribution to Pennsylvania.
Description
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.
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Manufacturer(s)
Numed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →