FDA-Device2025-05-21Class II
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc
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.
Sold states
US distribution to Pennsylvania.
Affected count
4 units
Manufactured in
2880 Main Street /Rt 11b, Hopkinton, NY, United States
Products
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2025Don't want to check this manually?
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