FDA Recall
Terminated
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Recall: Z-1754-2025
·
Initiated April 21, 2025
Recall
- Recall Number
- Z-1754-2025
- Event Number
- 96734
- Firm
- Numed Inc
- FEI Number
- 1318694
- Product Code
- NVM
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- April 21, 2025
- Posted
- May 13, 2025
- Terminated
- December 17, 2025
- Address
- 2880 Main Street, Rt 11b, Hopkinton, NY, 12965
Description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
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.
Action
NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at [email protected].
Distribution
US distribution to Pennsylvania.
Quantity
4 units