Home / Recalls / Greiner Bio-One North America, Inc. / Z-0502-2022

Z-0502-2022 Class II Terminated

Recalled by Greiner Bio-One North America, Inc. — Monroe, NC

FDA device recall Z-0502-2022 was initiated by Greiner Bio-One North America, Inc. on December 9, 2021 and is designated Class II. Reason for recall: Some of the blood collection tubes show clotting due to variation of Lithium Heparin. The recall status is terminated (terminated October 10, 2023). Affected quantity: 889,200 pcs..

Recall Details

Product Type
Devices
Report Date
January 26, 2022
Initiation Date
December 9, 2021
Termination Date
October 10, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
889,200 pcs.

Product Description

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

Reason for Recall

Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

Distribution Pattern

Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.

Code Information

Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.

Other recalls by Greiner Bio-One North America, Inc.

  • Z-0571-2026 Class II — Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Mod (August 19, 2025)
  • Z-0408-2026 Class II — Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 (August 8, 2025)
  • Z-2375-2024 Class II — VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ri (May 14, 2024)
  • Z-0733-2024 Class II — VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 gre (December 12, 2023)
  • Z-1583-2023 Class II — greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-r (March 31, 2023)
  • Z-2507-2021 Class II — Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 bl (August 20, 2021)
  • Z-2485-2021 Class II — VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged (August 13, 2021)
  • Z-1534-2021 Class II — VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue c (March 29, 2021)
  • Z-3027-2020 Class II — VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Pr (August 28, 2020)
  • Z-1714-2020 Class II — VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. (March 12, 2020)

FDA data resources