—#187910

Product

Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

FDA product code: DRE — Dilator, Vessel, For Percutaneous Catheterization
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K970392
Affected lot / code info: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023

Why it was recalled

The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

A letter and Acknowledgement Form sent on June 8, 2021 to each account. Actions requested on your part: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to determine if you have any units from the affected lots in your possession. Identify and set aside any units from the identified lots in a manner that ensures that the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cardinalhealth.com 4) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 5) Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product. For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 1, Monday through Friday from 9:00 AM to 5:00 PM EDT. For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00 AM to 8:00 PM EDT. For questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: GMB-CordisFieldAction@cardinalhealth.com or call (786) 313-2087.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.

Timeline

Recall initiated: 2021-06-09
Terminated: 2023-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.