Z-2485-2021Class II

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

Name: Z-2485-2021 VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Creator: Greiner Bio-One North America, Inc.
Published: 2021-08-13
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2021-08-13 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged on 2021-08-13. FDA classified it as Class II and gives the reason as "Blood collection tubes may experience a clotting issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2485-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-13
Posted: 2021-09-24
Terminated: 2023-08-16
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Blood collection tubes may experience a clotting issue.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter.
Quantity in commerce: 962,400 tubes
Distribution: Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
Product codes and lots: Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2485-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2485-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code JKA

K971236Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-12

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)