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

FDA device recall Z-0720-2023 · posted 2022-12-16 · Open, Classified

Recall details

Recalling firm

Cordis US Corp

Reason for recall

There is a potential for separation at the male connector.

Action taken

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 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: GMB-CordisFieldAction@cordis.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQO

Quantity affected

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 Republi

Date initiated

2022-11-07

Date posted

2022-12-16

Location

Miami Lakes, FL

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