Recall Z-1714-2020— Greiner Bio-One North America, Inc.

Name: FDA recall Z-1714-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-12

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2020-03-12, terminated 2022-08-31. It names one FDA 510(k) clearance: K971221. Product: VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.. Reason: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-12
Terminated: 2022-08-31
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

VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

Reason for recall

Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.

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