Vacuette 450086Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19120017570285), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K011786, K080235, K121908); 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Therapeutic or Diagnostic Output Failure

  CUSTOMER STATES AN RN REMOVED THE TUBING AND NEEDLE FROM THE GREINER BIO ONE BLOOD COLLECTION SET, LEAVING THE LUER CONNECTED TO THE TUBE HOLDER. SHE STARTED AN IV AND CONNECTED THE LUER AND TUBE HOLDER OF THE GREINER BIO ONE DIRECTLY TO THE HUB OF THE IV CATHETER. A LARGE AMOUNT OF BLOOD BEGAN FLOWING OUT FROM THE NEEDLE INSIDE THE TUBE HOLDER. THE RN WAS ABLE TO COLLECT THREE TUBES OF BLOOD. BETWEEN EACH TUBE COLLECTION, BLOOD CONTINUED TO FLOW FROM THE NEEDLE INSIDE THE TUBE HOLDER. AT SOME POINT DURING THIS BLOOD COLLECTION PROCESS, THE RN FELT A NEEDLESTICK TO RIGHT THUMB. THE RN THINKS THAT HER THUMB MUST HAVE SLIPPED INSIDE THE NEEDLE HOLDER AND BEEN PUNCTURED BECAUSE THERE WAS NO OTHER NEEDLE EXPOSED. DURING CLEAN-UP, THE RN FOUND THE GREY RUBBER SHEATH THAT NORMALLY COVERS THE NEEDLE INSIDE THE TUBE HOLDER ON THE FLOOR ABOUT SIX FEET AWAY. CUSTOMER CONFIRMS THIS WAS A VASCULAR DRAW. CUSTOMER ANSWERED NO TO ALL DECISION TREE QUESTIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9740716 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011786, K080235, K121908. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2013 · Feb 1, 2013 · Terminated
  VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipunc
• Z-0797-03 · Mar 10, 2003 · Terminated
  Vacuette, Safety Blood Collection Set with Luer Adapter