Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 recall
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in…
Why was Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 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: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
- Product
- Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in…
- Recalling firm
- Arrow International Inc
- Quantity
- 48 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)