FDA recall Z-0174-2023

Becton Dickinson Infusion Therapy Systems Inc. · Class II · device

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 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).

Distribution

U.S.: New York, Florida, Maryland, North Carolina, Virginia, Georgia, Rhode Island, New Jersey, Pennsylvania, Illinois, South Carolina, Maine, and Massachusetts. O.U.S.: N/A

Key facts

Status: Ongoing
Initiation date: 2022-10-12
Report date: 2022-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sandy, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2023