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U.S. Department of Health and Human Services

Class 2 Device Recall Cordis Angiographic Catheter Extensions

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  Class 2 Device Recall Cordis Angiographic Catheter Extensions see related information
Date Initiated by Firm November 07, 2022
Date Posted December 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0720-2023
Recall Event ID 91138
510(K)Number K970854  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Cordis Angiographic Catheter Extensions.

Used to transport fluid from the power injector to the catheter for injection into the patient.
Code Information UDI-DI: (01)2070532064702; Catalog Number (Lot Number): 502-100D (18068258, 18069744, 18101041, 18111609); 502-101D (18062881, 18081307, 18064731, 18086388, 18066535, 18097369, 18070824, 18102623, 18077497); 502-102D (18060997, 18078225, 18099118, 18062882, 18079156, 18104313, 18064732, 18083133, 18106093, 18072508, 18084892, 18108019, 18074058, 18088193, 18109512, 18076420, 18090247)
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		 There is a potential for separation at the male connector.
FDA Determined
Cause 2		 Under Investigation by firm
Action Cordis notified consignees on approximately 11/07/2022 via letter titled "Urgent MEDICAL DEVICE RECALL" sent to the Materials Director and Risk Manager. The letter instructed consignees to identify and segregate any affected product on hand, complete and return the Acknowledgement Form by email: GMB-CordisFieldAction@cordis.com, and return all affected product. Additionally, customers were instructed to share the 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. OUS consignee notification will be conducted by Cordis affiliates in the affected countries / regions. 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@cordis.com.
Quantity in Commerce 16,950 units (2,915 US and 14,000 OUS)
Distribution Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.
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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