Class 2 Device Recall BD Cathena" Safety IV Catheter

• Date Initiated by Firm: April 21, 2025
• Date Posted: May 21, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1808-2025
• Recall Event ID: 96696
• 510(K)Number: K220584
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
• Code Information: REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: 801-565-2300
• Manufacturer Reason for Recall: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
• FDA Determined Cause: Process control
• Action: On 4/21/2025, Removal notices were sent (mail/email/fax/phone) to Medical Directors, Risk Managers, Medical Device Safety Officers, Nurse Managers, and distributors were informed of the following: - Routine clinical practice of PPE should protect the clinician from mucocutaneous blood exposure. - If leakage from the septum occurs during insertion, the PIVC should no longer be used. It is recommended the clinician places a new PIVC. In addition, they were asked to do the following: 1) Destroy all unused product subject to the recall following your institution's process for destruction. 2. For indwelling catheters, no further action is needed. 3. If a defective product was previously used on a patient with no issues, no further actions are needed. 4. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 5. Complete and return Customer Response Form via email to Email: BDRC6@bd.com 6. Distributors were asked to identify all customers within their distribution network that purchased any affected product. Then, Provide a copy of the attached customer letter to all customers to advise them of this field action notification. Questions or complaints can be reported to the North American Regional Complaint Center, 1-844-823-5433 Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
• Quantity in Commerce: 262,800
• Distribution: Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ