Z-0720-2023Class II

Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for...

Name: Z-0720-2023 Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for...
Creator: Cordis US Corp
Published: 2022-11-07
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2022-11-07 / Open, Classified

FDA source

Cordis US Corp began a recall of Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient on 2022-11-07. FDA classified it as Class II and gives the reason as "There is a potential for separation at the male connector". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0720-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-07
Posted: 2022-12-16
Recalling firm: Cordis US Corp.
Product: Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: There is a potential for separation at the male connector.
FDA root cause: 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: [email protected], 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: [email protected].
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0720-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0720-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15

Product code DQO

K970854Class II5 Fr and 6 Fr Infiniti Angiographic CatheterCordis Corp. / cleared 1997-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)