FDAClass IIDecember 21, 2022

Cordis Angiographic Catheter Extensions. Used to recall

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

Why was Cordis Angiographic Catheter Extensions. Used to recalled?

There is a potential for separation at the male connector.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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)

Product
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Recalling firm
Cordis US Corp
Quantity
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.
Recall date
December 21, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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