Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. recall
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary…
Why was Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. 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: 16F20C0035 16F20F0124
- Product
- Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary…
- Recalling firm
- Arrow International Inc
- Quantity
- 5 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)