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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