Vacuette 450263DRecalls & reported problems
Greiner Bio-One GmbH · HOLDEX® Single-Use Holder PP single-packed, sterile, with lid on the inner packaging · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 29120017577588), received between Feb 24, 2020 and Feb 24, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K980768); 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
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2020Leak/Splash; Infusion or Flow Problem
DURING THE USE OF 450263DE PROBLEMS IN REGARDS TO BLOOD COLLECTION WERE OBSERVED. NO BLOOD FLOW DURING COLLECTION PROCEDURE AND LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9745902 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K980768. One submission often covers many models, so check the product and lot details in each record.
- Z-2957-2011 · Jun 29, 2011 · TerminatedHOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy b
- Z-2198-2008 · Aug 5, 2008 · TerminatedPlastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula
- Z-2134-2008 · May 16, 2008 · TerminatedVacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on t
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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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