Vanguard Reprocessed Compression Garment

• • Terminated Z-0272-2018 FDA Class II ·initiated 1 Dec 2017

  3040 compression sleeves being mislabeled as a 3010-PL compression sleeves.

• 5 recalls, same reason

  • Terminated Z-1661-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1672-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1671-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1676-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008
  • Terminated Z-1666-2008 FDA Unclassified (pre-2012) ·initiated 11 Mar 2008

  Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

510(k) Number

K012403 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vanguard Reprocessed Non-Electric Biopsy Forceps

  Class I

  FDA 510(k) K042594 Active Cleared 25 Jan 2005

• Vanguard Reprocessed Femoral Compression Device

  Class II

  FDA 510(k) K011832 Active Cleared 21 Dec 2001

• Vanguard Reprocessed Diagnostic Electrophysiology Catheters

  Class II

  FDA 510(k) K042074 Active Cleared 9 Mar 2005

• Reprocessed Disposable Cutters, Staplers and Appliers

  Class II

  FDA 510(k) K032973 Active Cleared 18 Dec 2003

• Vanguard Reprocessed Dilating Tip and Blunt Trocars

  Class II

  FDA 510(k) K043253 Active Cleared 8 Apr 2005

• Vanguard Reprocessed External Fixation Devices

  Class II

  FDA 510(k) K031687 Active Cleared 30 Apr 2004

See all devices from Vanguard Medical Concepts, Inc. →

• What is the Vanguard Reprocessed Compression Garment used for?

  The Vanguard Reprocessed Compression Garment is designed as a sleeve for limb compression, intended to be used with external air compression pumps. It applies graduated pressure to patient extremities to prevent blood pooling and improve venous return, primarily in cardiovascular therapy settings. The inflatable bladders within the garment create the necessary compression when paired with a compatible pump.

• How is the Vanguard Reprocessed Compression Garment supplied and prepared for use?

  This device is supplied as a reprocessed, single-use item. It undergoes cleaning, inspection, testing, and ethylene oxide sterilization by the manufacturer before distribution. Each garment is intended for one-time clinical use by healthcare staff in hospitals or outpatient facilities, ensuring sterility and safety for patient application.

• Is the Vanguard Reprocessed Compression Garment sterile and reusable?

  No, the Vanguard Reprocessed Compression Garment is not reusable. It is supplied as a single-use item after undergoing ethylene oxide sterilization during reprocessing. This ensures sterility and compliance with clinical standards for patient safety.

• What sizes or models are available for the Vanguard Reprocessed Compression Garment?

  The device is categorized under FDA product code JOW and is classified as a *Sleeve, Limb, Compressible* device. While specific size variations (e.g., pediatric, adult, or custom-fit models) are not detailed in the provided data, the garment is designed to fit standard limb sizes for external air compression therapy. For precise sizing, refer to manufacturer specifications or consult clinical guidelines.

• How should the Vanguard Reprocessed Compression Garment be stored?

  The reprocessed garment should be stored in its original, sealed packaging to maintain sterility until use. After opening, it must be used immediately as a single-use item. Storage conditions should comply with manufacturer guidelines to prevent contamination or degradation, typically in a clean, dry environment away from direct sunlight or extreme temperatures.