Vacuette 454021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 29120017571708), received between Feb 21, 2020 and Feb 21, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Suction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (BK030001, BK040018, K042927, K960860); 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, 2020Suction Problem

  AS INFORMED BY (B)(6), CUSTOMER "(B)(6) HOSPITAL ASSOCIATION" COMPLETED AN MDR ON FEBRUARY 12, 2018. REASON FOR THE MDR WAS LACK OF VACUUM AND AS A RESULT BLOOD COLLECTION TUBES WEREN'T FILLED COMPLETELY. ON FRIDAY (B)(6) 2018, GREINER BIO-ONE RECEIVED INFORMATION FROM (B)(6). CUSTOMER ( (B)(6)) WAS IMMEDIATELY CONTACTED ON MONDAY (B)(6) 2018 AND ACCORDING TO CUSTOMER'S INFORMATION, SAFETY OF PATIENT, USER OR THIRD WERE NOT NEGATIVELY INFLUENCED. THE EVENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. CUSTOMER DID NOT SEND AN OFFICIAL COMPLAINT TO GREINER BIO-ONE ON THE DATE THAT THE INFORMATION WAS RECEIVED FROM (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742376 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under BK030001, BK040018, K042927, K960860. One submission often covers many models, so check the product and lot details in each record.

• Z-1583-2023 · Mar 31, 2023 · Completed
  greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003