Recall Z-0720-2023 ยท DQO Catheter, Intravascular, Diagnostic
Cordis US Corp
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
| Date | Dec 16, 2022 (initiated Nov 7, 2022) |
| Status | Open, Classified |
| Reason | There is a potential for separation at the male connector. |
| 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: 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970854 | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER Cordis Corp., Sep 30, 1997 |