FDAFDA · Food and drugs·Recall number Z-1754-2025
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Published May 21, 2025 · Recall initiated: April 21, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Numed Inc
- Distributor
- US distribution to Pennsylvania.
- Lot
- Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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