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A6 Luer Access Device

by B. Braun Medical, Inc.

510(k) K083723

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

56 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083723 Date5 Jun 2009ClearedStatusActive

Recalls

66 recalls · 56 ongoing · FDA

  • 52 recalls, same reason

    • Ongoing Z-0689-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0657-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0617-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0683-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0698-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0653-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0694-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0696-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0707-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0692-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0656-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0625-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0699-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0662-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0688-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0695-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0622-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0612-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0659-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0624-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0610-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0663-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0607-2026 FDA Class II initiated 29 Oct 2025 on shared 510(k) K083723
    • Ongoing Z-0709-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0627-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0691-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0614-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0628-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0704-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0684-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0652-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0690-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0706-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0661-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0615-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0658-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0660-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0633-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0626-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0693-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0703-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0619-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0687-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0664-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0655-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0616-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0715-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0676-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0716-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0654-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0685-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-0609-2026 FDA Class II initiated 29 Oct 2025

    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

  • 2 recalls, same reason

    • Ongoing Z-2376-2024 FDA Class II initiated 17 Jun 2024
    • Ongoing Z-2377-2024 FDA Class II initiated 17 Jun 2024

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    • Ongoing Z-0091-2023 FDA Class II initiated 15 Sep 2022

    The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

    • Ongoing Z-0092-2023 FDA Class II initiated 15 Sep 2022

    The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.

  • 7 recalls, same reason

    • Terminated Z-2547-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2546-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2544-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2548-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2552-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2556-2021 FDA Class II initiated 10 Aug 2021
    • Terminated Z-2545-2021 FDA Class II initiated 10 Aug 2021

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

  • 3 recalls, same reason

    • Terminated Z-0936-2020 FDA Class II initiated 20 Nov 2019
    • Terminated Z-0938-2020 FDA Class II initiated 20 Nov 2019
    • Terminated Z-0937-2020 FDA Class II initiated 20 Nov 2019

    Potential for leakage at the joint between the blood filters and tubing

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FPA
FDA applicant
B.Braun Medical, Inc.
Device class
Class II
Regulation
21 CFR Part 880.5440
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The A6 Luer Access Device is an intravascular administration set component designed to facilitate secure connections within a clinical setting. It functions as a needleless connector that allows for the attachment of Luer-compatible devices, such as syringes or IV sets, to support fluid administration.

This device is identified under FDA 510(k) clearance K083723. It is intended for use in general hospital environments to maintain system integrity during intravascular access procedures.

From the manufacturer

CARESITE Micro® Luer Access Device -. The CARESITE Micro Device provides a solid grip and secure connection with minimal force upon attachment of a Luer connector.

Source: bbraunusa.com

Other devices from B. Braun Medical, Inc.

See all devices from B. Braun Medical, Inc. →

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the A6 Luer Access Device?

    The A6 Luer Access Device serves as a needleless connector within an intravascular administration set. It is designed to facilitate secure connections between Luer-compatible devices, such as syringes or IV sets, to support the administration of fluids while maintaining system integrity.

  • In what clinical settings is this device intended to be used?

    This device is intended for use in general hospital environments. It is designed to assist clinicians in maintaining the integrity of intravascular access systems during routine fluid administration procedures.

  • What is the regulatory status of the A6 Luer Access Device?

    The A6 Luer Access Device has received FDA 510(k) clearance under the number K083723. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.