Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring pe
Summary
The FDA issued a Class II for Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in art by Cordis Corporation. Reason: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates..
Details
Source
Device Recall
External ID
Z-2079-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Lot/Code Info: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023
Quantity Affected: 680 units
Reason for Recall
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-09
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis Corporation have FDA actions?
Cordis Corporation has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2079-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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