Z-1754-2025 Class II Terminated
FDA device recall Z-1754-2025 was initiated by Numed Inc on April 21, 2025 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 17, 2025). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 21, 2025
- Termination Date
- December 17, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reason for Recall
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.
Distribution Pattern
US distribution to Pennsylvania.
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.