Recall Z-1808-2025 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Becton Dickinson Infusion Therapy Systems, Inc.
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
| Date | May 21, 2025 (initiated Apr 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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. Fo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220584 | BD Cathena Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc., Mar 31, 2022 |