BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reported: May 21, 2025 Initiated: April 21, 2025 #Z-1754-2025
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.
Details
- Recalling Firm
- Numed Inc
- Units Affected
- 4 units
- Distribution
- US distribution to Pennsylvania.
- Location
- Hopkinton, NY
Frequently Asked Questions
What product was recalled? ▼
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420. Recalled by Numed Inc. Units affected: 4 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2025. Severity: Moderate. Recall number: Z-1754-2025.
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