Z-0447-03

Microtainer Brand Tube with EDTA (K2), Catalog Number 365974

Name: Z-0447-03 Microtainer Brand Tube with EDTA (K2), Catalog Number 365974
Creator: Becton Dickinson & Company
Published: 2002-10-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2002-10-16 / Terminated

FDA source

Becton Dickinson & Company began a recall of Microtainer Brand Tube with EDTA (K2), Catalog Number 365974 on 2002-10-16. The reason FDA records is "Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0447-03
Status: Terminated
Initiated: 2002-10-16
Posted: 2003-01-16
Terminated: 2004-04-15
Recalling firm: Becton Dickinson & Co
Product: Microtainer Brand Tube with EDTA (K2), Catalog Number 365974.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.
FDA root cause: Other
Action: Becton Dickinson contacted their Distributors and customers with return instructions via certified mail on or about Oct. 16, 2002.
Quantity in commerce: 141600
Distribution: The firm distributed this product nationwide to wholesalers and direct customers.
Product codes and lots: Lot #2098765

Product code JKA

K940905Class IIMicrotainer Brand Tube with Edta(k2)Bd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1994-08-02

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)