—#143414

Product

CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

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 No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.

Why it was recalled

Incorrect cannula of the sheath introducer (smaller than intended).

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The firm, Cordis, sent an 'Urgent MEDICAL DEVICE CORRECTION (Field Safety Notice) dated 12/31/2015 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Read the Description of the problem section carefully to fully understand the issue involved. 2) Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product. 3) Keep a copy of this notice with any affected product. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis by fax to (908) 429-8287 Alternate fax (904) 928-5077. number or scan and email to MiamiFRA@its.jnj.com. 5) Share this letter with anyone who needs to be informed in your facility and in any facility where potentially affected devices may have been transferred. 6) Maintain awareness of this notice until all affected product has been consumed. If vessel dilator to sheath incompatibility is experienced, you can report the incident through the standard complaint process (1-800-327-7714 Option 3). For any health care professional with medical concerns, please contact Cordis to speak to a clinician at 1-800-327-7714 Option 3, Monday through Friday from 9:00 AM to 5:00 PM EST. For questions related to the Correction that are not adequately addressed in this letter, please contact the Cordis Field Action Coordinator at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730."

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.

Timeline

Recall initiated: 2015-12-31
Posted by FDA: 2016-03-15
Terminated: 2016-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.