Acacia Piston Syringe

• • Terminated Z-1262-2015 FDA Class II ·initiated 13 Feb 2015

  The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.

510(k) Number

K092986 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Spring Loaded Syringe

  Class II

  FDA 510(k) K931095 Active Cleared 16 Sep 1993

• Syringe Tip Adaptor

  Class II

  FDA 510(k) K894217 Active Cleared 12 Sep 1989

• Intopo

  Class II

  FDA 510(k) K894206 Active Cleared 27 Oct 1989

• Luer Lock Transfer Pin

  Class II

  FDA 510(k) K901063 Active Cleared 6 Jul 1990

• Blood Sampling Set

  Class II

  FDA 510(k) K103165 Active Cleared 10 Nov 2010

• Ophthalmic Dropper Bottles

  Not classified

  FDA 510(k) K850962 Active Cleared 21 Mar 1985

See all devices from Acacia, Inc. →

• What is the Acacia Piston Syringe used for?

  The Acacia Piston Syringe is designed for injecting fluids into or withdrawing fluids from the body. It serves as a dispenser and measuring device, ensuring accurate fluid transfer in medical procedures. The tapered male connectors (available in luer lock, luer slip, oral lock, or oral slip) make it versatile for various applications, including injections, infusions, or sample collection.

• Is the Acacia Piston Syringe single-use or reusable?

  This syringe is explicitly intended for single-use only. It is classified as a sterile medical instrument and must be discarded after one use to maintain aseptic practices and prevent contamination. Reuse violates manufacturer guidelines and poses infection risks.

• What connector types does the Acacia Piston Syringe support?

  The syringe features tapered male connectors in four configurations: luer lock, luer slip, oral lock, and oral slip. These designs ensure compatibility with a wide range of medical devices, adapters, and tubing systems, depending on the clinical application.

• How should the Acacia Piston Syringe be stored?

  Store the syringe in its original packaging in a clean, dry environment protected from direct sunlight and extreme temperatures. Ensure the packaging remains intact to preserve sterility until immediate use. Avoid exposure to moisture or chemical contaminants.

• What regulatory pathway was used for FDA clearance?

  The Acacia Piston Syringe was cleared through the Traditional 510(k) pathway (K092986) under the FDA’s General Hospital (FMF) product code. The submission was reviewed by the Orthopaedics and Rehabilitation Devices Panel (HO) and deemed substantially equivalent to a predicate device, with clearance granted on October 27, 2009.