Arrow Berman Angiographic Catheter 60cm recall
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Why was Arrow Berman Angiographic Catheter 60cm recalled?
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
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?
Lot Number: 16F19H0093
- Product
- Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Recalling firm
- Arrow International Inc
- Quantity
- 1 unit
- Distribution
- U.S. Nationwide, Canada
- Recall date
- December 25, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)