Vacuette 450095Recalls & reported problems
Greiner Bio-One GmbH · SAFETY Blood Collection Set + Luer Adapter 21G x 3/4" tubing length 12" (30 cm), single-packed, sterile, not made with natural rubber latex · 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 19120017570339), 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).
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
Device problems
- Detachment of Device or Device Component1
- Product Quality Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2020Product Quality Problem; Detachment of Device or Device Component
CUSTOMER STATES THERE HAVE BEEN 3 NEEDLE STICK INCIDENTS. IN ALL THREE NEEDLE STICK INCIDENTS, EACH PHLEBOTOMIST WAS ENGAGING THE SAFETY WITH HER RIGHT HAND AND STUCK A FINGER ON HER LEFT HAND. CUSTOMER STATES THERE HAVE BEEN 2 EVENTS OF BUTTERFLY NEEDLES BREAKING AWAY FROM THE END OF THE SAFETY. CUSTOMER ADVISES ALL INSTANCES OF NEEDLE STICK AND NEEDLE BREAKAGE EVENTS WERE NOT LIFE THREATENING; NO PERMANENT IMPAIRMENT OF BODY FUNCTION; NO PERMANENT DAMAGE TO A BODY STRUCTURE; AND NO MEDICAL OR SURGICAL INTERVENTION NEEDED.
Patient problems: Needle Stick/Puncture
MAUDE report 9738961 ↗
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 · TerminatedVACUETTE 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 · TerminatedVacuette, Safety Blood Collection Set with Luer Adapter
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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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