Z-0720-2023 Class II Ongoing
FDA device recall Z-0720-2023 was initiated by Cordis US Corp on Nov 7, 2022 and is designated Class II. Reason for recall: There is a potential for separation at the male connector. The recall status is ongoing. Affected quantity: 16,950 units (2,915 US and 14,000 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,950 units (2,915 US and 14,000 OUS)
Product Description
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Reason for Recall
There is a potential for separation at the male connector.
Distribution Pattern
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.
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0720-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026