Recall Z-1583-2023— Greiner Bio-One North America, Inc.

Name: FDA recall Z-1583-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-31

Class II · Completed

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2023-03-31. It names one FDA 510(k) clearance: K960860. Product: 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. Reason: Some of the tubes may be incorrectly labeled..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Completed
Initiated: 2023-03-31
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K960860 — GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3Greiner America, Inc.·cleared 1996-09-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Some of the tubes may be incorrectly labeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.