Z-0176-2012

BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated...

Name: Z-0176-2012 BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated...
Creator: Becton Dickinson & Company
Published: 2011-02-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-02-11 / Terminated / root cause: design

FDA source

Becton Dickinson & Company began a recall of BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants... on 2011-02-11. The reason FDA records is "BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0176-2012
Status: Terminated
Initiated: 2011-02-11
Posted: 2011-11-08
Terminated: 2011-11-10
Recalling firm: Becton Dickinson & Co
Product: BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.
Root cause tag: design
FDA root cause: Device Design
Action: A Becton Dickinson Sales Consultant conducted a "on-site" visit to the single Customer account, Florida Hospital, on February 11, 2011. All units were successfully recovered. All product recovered was quarantined and destroyed. Becton Dickinson believes that all reasonable efforts to communicate the issue to the affected consignee have been completed. If you have any questions or request additional information please do not hesitate to call (201) 847-5636.
Quantity in commerce: 10,800 units
Distribution: Distributed only to Florida.
Product codes and lots: Lot # 1018904 Catalog # 363706

Product code JKA

K093972Class IIBd Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO / cleared 2010-01-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)