Recall StatusOpen, Classified
Date Initiated2022-11-07
Product Quantity16,950 units (2,915 US and 14,000 OUS)
Reason for Recall
There is a potential for separation at the male connector.
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:
[email protected], 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:
[email protected].
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.