Reported May 21, 2025 · Terminated
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Numed Inc · 2880 Main Street /Rt 11b · Hopkinton, NY · 12965
Is this the product you have?
- BIB Balloon in Balloon Dilatation Catheter
- Model Number420
- Lot codes and dates
- Model Number 420
- UDI-DI04046964899768
- Lot NumbersBIB-16972 (Expiration
- date11/30/2028)
- BIB-16972-1 (Expiration date12/31/2028)
- Catheter Product CodeBB005
- Amount recalled
- 4 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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