Cordis ANGIOGRAPHIC CATHETERIZATION SETS…

Date

Nov. 15, 2023

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Ongoing

Filed by

Cordis US Corp

Product

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Reason

Non-sterile product labeled as sterile was distributed.

Distribution pattern

US Distribution to: OK

Quantity

30 devices

Codes and lots

UDI/DI 10705032025935, Lot Number 18223410

Recall started

Sept. 26, 2023

Device type

Catheter, Intravascular, Diagnostic

Root cause (FDA)

Process control

What the company told customers

The account representative for the consignee notified the consignee by phone on September 26, 2023, providing details of the issue and instructed them to quarantine the impacted lot. Cordis then issued an "Urgent MEDICAL DEVICE RECALL" notice to its sole consignee by letter on 09/28/2023. The notice explained the issue, potential risk, and requested the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory to confirm that you do not 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 the affected product will not be used. Check all storage and usage locations. 3) Review, complete, sign and return the Acknowledgement Form directly to Cordis by email to: GMB-CordisFieldAction@cordis.com 4) Return any affected product. 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. - For questions related to assistance returning product or billing concerns please contact your sales representative or Cordis Customer Support at 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT. 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 questions related to the recall and/or acknowledgement form that are not adequately addressed in this letter, please contact Cordis QA at: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.

Recall number

Z-0286-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0286-2024. The agency record governs; check it and the company before acting.