Recall Z-2485-2021— Greiner Bio-One North America, Inc.

Name: FDA recall Z-2485-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-13

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2021-08-13, terminated 2023-08-16. It names one FDA 510(k) clearance: K971236. Product: VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged. Reason: Blood collection tubes may experience a clotting issue..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-13
Terminated: 2023-08-16
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971236 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-12

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

VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

Reason for recall

Blood collection tubes may experience a clotting issue.

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