Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm recall
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies…
Why was Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm recalled?
Marketed without a 510K
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Lot Numbers: 16F19J0109
- Product
- Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies…
- Recalling firm
- Arrow International Inc
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)