Device product
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Z-0720-2023
Product summary
- Firm
- Cordis US Corp
- Event
- Event 91138
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,950 units (2,915 US and 14,000 OUS)
- Official record key
device-enforcement:Z-0720-2023
Official wording
Reason: There is a potential for separation at the male connector.
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)
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.
Derived failure modes
-
Unknown
There is a potential for separation at the male connector.