Recall Z-1754-2025— Numed Inc
Class II · Terminated
Class II FDA medical device recall by Numed Inc, initiated 2025-04-21, terminated 2025-12-17. It names one FDA 510(k) clearance: K050857. Product: 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..
- Recalling firm
- Numed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2025-04-21
- Terminated
- 2025-12-17
- Firm location
- Hopkinton, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.