Z-2507-2021Class II

Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich...

Name: Z-2507-2021 Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich...
Creator: Greiner Bio-One North America, Inc.
Published: 2021-08-20
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2021-08-20 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged on 2021-08-20. FDA classified it as Class II and gives the reason as "Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2507-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-20
Posted: 2021-09-22
Terminated: 2023-10-04
Recalling firm: Greiner Bio-One North America, Inc.
Product: Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
Reason for recall: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
FDA root cause: Under Investigation by firm
Action: A letter was sent on August 20, 2021 with the following actions: Necessary actions: We need your assistance to address this recall. Please perform the following steps. " Stop using the above-mentioned product (concerned item/lot) immediately and isolate defective products in your facility. " Assess risks and consequences for the use of this defective product in accordance with your procedures and take appropriate action. " Complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 800.726.0052 or email to [email protected]. This form is to confirm that you have discarded/destroyed all products from these items/lots. We will replace the product after the completed form is sent to Greiner. If you have additional questions, please call our Technical Service at 800-515-8112.
Quantity in commerce: 956,400
Distribution: US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.
Product codes and lots: Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2507-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2507-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22

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)