Recall Z-1754-2025
Numed Inc · initiated April 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Codes / lots: 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.
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
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 nlaflesh@numedusa.com.
Details
- Recall number
- Z-1754-2025
- Initiated
- April 21, 2025
- Posted by FDA
- May 13, 2025
- Terminated
- December 17, 2025
- Product code
- NVM – Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon
- Quantity
- 4 units
- Distribution
- US distribution to Pennsylvania.
- Recalling firm
- Numed Inc, Hopkinton, NY