Recall Z-2507-2021— Greiner Bio-One North America, Inc.

Name: FDA recall Z-2507-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-20

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2021-08-20, terminated 2023-10-04. It names one FDA 510(k) clearance: K971221. Product: Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged. Reason: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-08-20
Terminated: 2023-10-04
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971221 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-02

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 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Reason for recall

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

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