Z-1714-2020Class II

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

Name: Z-1714-2020 VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355
Creator: Greiner Bio-One North America, Inc.
Published: 2020-03-12
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2020-03-12 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355 on 2020-03-12. FDA classified it as Class II and gives the reason as "Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1714-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-12
Posted: 2020-04-15
Terminated: 2022-08-31
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
Reason for recall: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
FDA root cause: Process change control
Action: Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112.
Quantity in commerce: 1,000,800 units.
Distribution: US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.
Product codes and lots: Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1714-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1714-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-15

Product code GIM

K971221Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)