Recall Z-0174-2023— Becton Dickinson Infusion Therapy Systems Inc.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems Inc., initiated 2022-10-12. It names one FDA 510(k) clearance: K183399. Product: BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr). Reason: During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed)..
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-12
- 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 Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Reason for recall
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Data sourced from openFDA. This site is unofficial and independent of the FDA.