BIB Balloon in Balloon Dilatation Catheter recall
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Why was BIB Balloon in Balloon Dilatation Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
- Recalling firm
- Numed Inc
- Quantity
- 4 units
- Distribution
- US distribution to Pennsylvania.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)