Vacuette 454008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 29120017579032), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K960857); 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.

• MalfunctionFeb 21, 2018Material Deformation

  EMPLOYEE GRABBED A VACUETTE GREEN TOP SAMPLE TUBE AND NOTICED THAT PRODUCT WAS DEFORMED AND COULD NOT BE USED FOR SAMPLE COLLECTION. UPON CHECKING OTHER TUBES IN SAME LOT NUMBER, OTHERS WERE FOUND TO BE DEFECTIVE AND NON-USABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960857. One submission often covers many models, so check the product and lot details in each record.

• Z-0502-2022 · Dec 9, 2021 · Terminated
  greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
• Z-1081-2012 · Dec 14, 2011 · Terminated
  LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
• Z-0623-2011 · Aug 25, 2010 · Terminated
  Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
• Z-0215-2009 · Jul 29, 2008 · Terminated
  VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufact