Z-1011-2010

BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in part...

Name: Z-1011-2010 BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in part...
Creator: Becton Dickinson & Co.
Published: 2009-11-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-11-11 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***... on 2009-11-11. The reason FDA records is "The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1011-2010
Status: Terminated
Initiated: 2009-11-11
Posted: 2010-03-08
Terminated: 2010-05-13
Recalling firm: Becton Dickinson & Co
Product: BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
Product code: MDB System, Blood Culturing
Reason for recall: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
FDA root cause: Component change control
Action: An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 526,650 bottles
Distribution: Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
Product codes and lots: 9267166 exp 10/31/2010 9267168 exp 10/31/2010 9267170 exp 10/31/2010 9267173exp 10/31/2010 9267175 exp 10/31/2010 9267177 exp 10/31/2010 9267180 exp 10/31/2010 9268357 exp 10/31/2010 9268358 exp 10/31/2010

Product code MDB

K921133Class IBactec Plus Aerobic/f and Anaerobic/f MediaBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1992-04-22

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)