Vacuette 456073PRecalls & reported problems
Greiner Bio-One GmbH · VACUETTE® TUBE 5 ml Z Serum Separator Clot Activator 13x100 red cap-yellow ring, non-ridged · 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 29120017572897), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
4 other recalls cover devices cleared under the same FDA submission (BK040066, BK050028, K960858, K983952); 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
Patient problems
- Exposure to Body Fluids1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2020Detachment of Device or Device Component
CUSTOMER STATES NURSE WAS GENTLY ROTATING GOLD TOP TUBE OF BLOOD SPECIMEN BACK AND FORTH WHILE WALKING. NURSES ADVISED THAT THE TOP OF THE TUBE POPPED-OFF. BLOOD SPLATTERED ONTO THE NURSE'S FACE INCLUDING LIP (BUT NOT IN EYES OR MOUTH), ON NECK, SHIRT, AND RIGHT ARM. BLOOD ALSO SPRAYED ON THE FLOOR. NURSE IMMEDIATELY WASHED ALL SPLATTERED AREAS OF BODY WITH SOAP AND WATER. NURSE WAS REFERRED TO HOSPITAL POLICY REGARDING EMPLOYEE EXPOSURE TO BLOOD-BORNE PATHOGENS AND SENT THE NURSE TO EMPLOYEE HEALTH.
Patient problems: Exposure to Body Fluids
MAUDE report 9739247 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under BK040066, BK050028, K960858, K983952. One submission often covers many models, so check the product and lot details in each record.
- Z-0571-2026 · Aug 19, 2025 · Open, ClassifiedBrand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Ac
- Z-2375-2024 · May 14, 2024 · Open, ClassifiedVACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
- Z-0818-2020 · Nov 25, 2019 · TerminatedVACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood
- Z-0086-06 · Jul 28, 2005 · TerminatedSerum Blood Collection Tubes
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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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