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U.S. Department of Health and Human Services

Class 1 Device Recall Cordis INFINITI

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  Class 1 Device Recall Cordis INFINITI see related information
Date Initiated by Firm September 26, 2023
Date Posted November 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0286-2024
Recall Event ID 93174
510(K)Number K970854  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Code Information UDI/DI 10705032025935, Lot Number 18223410
Recalling Firm/
Manufacturer		 Cordis US Corp
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer Reason
for Recall		 Non-sterile product labeled as sterile was distributed.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 30 devices
Distribution US Distribution to: OK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = CORDIS CORP.
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