Vacuette 450228Recalls & reported problems
Greiner Bio-One GmbH · VACUETTE® QUICKSHIELD Complete PLUS 22G x 1 1/2" single-packed, sterile 0.7 x 38 mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 19120017577758), received between Feb 18, 2020 and Feb 21, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K072320); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Disconnection1
- Fail-Safe Did Not Operate1
Patient problems
- Exposure to Body Fluids1
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2020Disconnection; Detachment of Device or Device Component
CUSTOMER STATES NEEDLE HAS DISCONNECTED FROM THE HOLDER DURING PHLEBOTOMY; TUBES FLEW OFF THE NEEDLE AND ACROSS THE ROOM; AND CAP POPPED OFF SPLATTERING BLOOD ON PHLEBOTOMIST'S FACE.
Patient problems: Exposure to Body Fluids
MAUDE report 9740435 ↗InjuryFeb 18, 2020Fail-Safe Did Not Operate
CUSTOMER STATES: "THE NEEDLE BENDS EXCESSIVELY WHILE ACTIVATING THE SAFETY SHIELD. THIS HAS BEEN A CONTINUOUS COMPLAINT FROM ALL MY PHLEBOTOMIST. THERE HAVE BEEN 4 RECENT INCIDENTS WHERE THE NEEDLE HAS BENT OUT OF THE SAFETY SHIELD WHILE BEING ACTIVATED AND SAFETY CLICK WAS HEARD. ONE INCIDENT RESULTED IN ONE OF THE PHLEBOTOMIST BEING STUCK WITH A USED NEEDLE. THE PHLEBOTOMIST ACTIVATED THE SHIELD AND HEARD THE CLICK. SHE PLACED THE VACUETTE DOWN BEDSIDE TO BANDAGE THE PATIENT AND WAS STUCK WHEN SHE REACHED TO DISPOSE OF THE VACUETTE."
Patient problems: Needle Stick/Puncture
MAUDE report 9720563 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K072320. One submission often covers many models, so check the product and lot details in each record.
- Z-1935-2012 · Apr 2, 2012 · TerminatedVacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a sy
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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