Device product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Z-1754-2025
Product summary
- Firm
- Numed Inc
- Event
- Event 96734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1754-2025
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: US distribution to Pennsylvania.
Derived failure modes
-
Unknown
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.