Disposable Syringe Fill Tube

• • Terminated Z-0815-2012 FDA Unclassified (pre-2012) ·initiated 20 Dec 2011

  The firm received complaints from their customers stating that they found open seals on two of their sterilized products.

• • Terminated Z-0830-2012 FDA Unclassified (pre-2012) ·initiated 11 Oct 2011 ·on shared 510(k) K781334

  Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.

• • Terminated Z-2081-2012 FDA Class II ·initiated 1 Feb 2010

  A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.

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

510(k) Number

K781334 ↗

FDA Product Code

DXT

Device Class

Class II

Regulation

21 CFR Part 870.1650

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Angiomat 6000

  Class II

  FDA 510(k) K860204 Active Cleared 2 May 1986

• Automatic Cassette Loader

  Class II

  FDA 510(k) K902761 Active Cleared 9 Oct 1990

• X-Ray Film, Convey or System

  Class II

  FDA 510(k) K760279 Active Cleared 13 Aug 1976

• Hydrajust IV Urological Table

  Class II

  FDA 510(k) K920742 Active Cleared 27 Apr 1992

• Neuro Vision Radiographic X-Ray System

  Class II

  FDA 510(k) K904146 Active Cleared 13 Dec 1990

• L-F Coiled Extension Tubing

  Class II

  FDA 510(k) K882329 Active Cleared 2 Sep 1988

See all devices from Mallinckrodt Group, Inc. →

• What is the Disposable Syringe Fill Tube used for?

  The Disposable Syringe Fill Tube is designed specifically for angiographic procedures to facilitate the accurate filling of syringes with contrast media or other fluids. Its purpose is to ensure precise dosing while minimizing contamination risks during preparation, which is critical in sterile environments like radiology departments.

• Is the Disposable Syringe Fill Tube reusable or single-use?

  This device is explicitly intended for single-use only. It is classified as a disposable item and must be discarded after one use to maintain sterility and prevent cross-contamination in clinical settings.

• What regulatory approval does the Disposable Syringe Fill Tube hold?

  The Disposable Syringe Fill Tube is FDA-cleared under the 510(k) pathway with the classification number K781334. It falls under regulation number 870.1650 and is categorized under the product code DXT, confirming its compliance for use in angiographic procedures.

• How is the Disposable Syringe Fill Tube supplied, and what should be considered for storage?

  While the exact packaging details are not specified, the device is supplied as a sterile, single-use item, meaning it should be stored in its original, unopened packaging to preserve sterility. Ensure the storage environment is clean, dry, and protected from contamination until use.

• Does the Disposable Syringe Fill Tube have any specific safety considerations for use in imaging environments?

  The provided information does not specify MRI safety details for this device. Clinicians should verify compatibility with their imaging equipment and protocols, particularly if used in environments with magnetic resonance systems, to avoid potential interference or safety risks.