medical Class II Updated 2025-05-21

Numed Inc recalls BIB Balloon in Balloon Dilatation Catheter. Model Number: 42

Recalled Product

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420


Hazard / Issue

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.

Issued by

FDA

Distribution: US distribution to Pennsylvania.
Lot/Code Info: 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.
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