Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 Recalled by Numed Inc Due to Balloon extension lumens are not printed correctly. Specifically,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Numed Inc directly.
Affected Products
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Quantity: 4 units
Why Was This Recalled?
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.
Where Was This Sold?
US distribution to Pennsylvania.
About Numed Inc
Numed Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report