Avanti¿+ Catheter Sheath Introducer - Product Usage: Is recall: Labeling Error
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of…
Why was Avanti¿+ Catheter Sheath Introducer - Product Usage: Is recalled?
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
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?
Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023
- Product
- Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of…
- Recalling firm
- Cordis Corporation
- Quantity
- 680 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)