# K072320: Greiner Vacuette Quickshield Complete

- Pathway: 510(k) (Special)
- Applicant: Greiner Bio-One North America, Inc.
- Decided: Sep 14, 2007 after 25 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972404 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033478: Vacuette Quickshield Safety Tube Holder, Greiner Bio-One Vacuette North America (2003) Summary page 1.
- K973620: Vacuette Multi-Sample Needle, Greiner Meditech, Inc. (1997) Summary page 1.
- K061483: Vacuette Visio Plus Blood Collection Needles, Greiner Bio-One North America, Inc. (2006) Summary page 1.

## Most influential descendants
- K233979: VACUETTE® QUICKSHIELD Complete (Plus) (2024), 0 descendants of its own

## Recalls of this device
- Apr 2, 2012 · Class II · Z-1935-2012: : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.

## Indications for use
The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

Source page: https://510kreport.com/device/K072320
Methodology: https://510kreport.com/methodology