Recall Z-1808-2025— Becton Dickinson Infusion Therapy Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems, Inc., initiated 2025-04-21. It names one FDA 510(k) clearance: K220584. 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. 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..
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-21
- Firm location
- Sandy, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.