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Recall Observatory FDA recall evidence

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)

Z-0174-2023

October 12, 2022

Class II

Product summary

Firm
Becton Dickinson Infusion Therapy Systems Inc.
Event
Event 90972
Status
Ongoing
Classification
Class II
Quantity
56,080 units
Official record key
device-enforcement:Z-0174-2023

Official wording

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).

Code information: Catalog Number: 383516 UDI-DI Code: (01)00382903835164 Lot Number: 2168865

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).