Vacuette 450082Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 19120017570247), received between Nov 20, 2018 and Feb 21, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Retraction Problem; Material Twisted/Bent

  CUSTOMER ADVISED THAT WHEN PHLEBOTOMIST USED THE DEVICE IT WOULD TWIST BACK ONTO ITSELF REQUIRING THE PHLEBOTOMIST TO ANCHOR THE DEVICE WHILE TERMINATING THE VENIPUNCTURE AND REMOVING THE NEEDLE FROM THE PATIENT'S ARM. CUSTOMER STATED THAT UPON TERMINATING THE VENIPUNCTURE AND ACTIVATING THE SAFETY MECHANISM, THE NEEDLE DID NOT FULLY RETRACT AS DESIGNED. CUSTOMER CONFIRMED A NEEDLE RELATED BLOOD EXPOSURE OCCURRED BUT THERE WAS NO INJURY OR MEDICAL INTERVENTION REQUIRED. CUSTOMER ADDED THAT THE NEEDLE NOT RETRACTING AS DESIGN HAS HAPPENED WITH OTHER PHLEBOTOMISTS BUT COULD NOT ADVISE NUMBER OF OCCURRENCES. CUSTOMER CONFIRMED THEY HAVE HAD ONLY THE IDENTIFIED LOT NUMBER IN USE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 9741172 ↗
• InjuryFeb 20, 2020Difficult to Remove

  CUSTOMER STATES A NURSE WAS UNABLE TO SHEATH NEEDLE COMPLETELY WHEN REMOVING THE NEEDLE FROM THE PATIENT'S ARM AND WAS STUCK WITH NEEDLE. THE NURSE WAS USING TWO-HANDS. IN A SEPARATE INCIDENT, THE CUSTOMER ADVISED THE NEEDLE STICK OCCURRED WHEN A NURSE WAS ATTEMPTING TO REMOVE SPONGE COVERED TIP DURING A SYRINGE BLOOD DRAW. CUSTOMER CONFIRMED THERE WAS NO LIFE-THREATENING, IMPAIRMENT, PERMANENT, OR NECESSARY SURGICAL INTERVENTION WITH THESE INCIDENTS.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 9732217 ↗
• MalfunctionNov 20, 2018Retraction Problem

  BLOOD COLLECTION SET TWISTS BACK ONTO ITSELF CAUSING THE PHLEBOTOMIST TO HAVE TO HOLD THE COLLECTION SET WHILE ATTEMPTING TO WITHDRAW NEEDLE. NEEDLE DOES NOT RETRACT COMPLETELY AS DESIGNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8088601 ↗

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