Recall Z-0502-2022— Greiner Bio-One North America, Inc.

Name: FDA recall Z-0502-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-09

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2021-12-09, terminated 2023-10-10. It names one FDA 510(k) clearance: K960857. Product: 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: Some of the blood collection tubes show clotting due to variation of Lithium Heparin..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-09
Terminated: 2023-10-10
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K960857 — GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATORGreiner America, Inc.·cleared 1996-08-30

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, 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.

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