Z-0643-2010

BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled...

Name: Z-0643-2010 BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled...
Creator: Becton Dickinson & Co.
Published: 2009-02-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2009-02-19 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7... on 2009-02-19. The reason FDA records is "In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms". 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-0643-2010
Status: Terminated
Initiated: 2009-02-19
Posted: 2010-01-15
Terminated: 2010-02-12
Recalling firm: Becton Dickinson & Co
Product: BBL (TM) Brain Heart Infusion, Catalog number 221778, package of 100 tubes, 0.5 mL tubes. Product is labeled in part *** Becton Dickinson and Company, 7 Loveton Circle, Sparks, Maryland 21152 USA*** 800-638-8663 A general purpose liquid medium used for the cultivation of bacteria employed in the preparation of inocula for microdilution minimal inhibitory concentration (MIC) and identification (ID) tests.
Product code: KZI Culture Media, Enriched
Reason for recall: In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The recalling firm notified direct accounts by an Urgent Product Recall letter on 02/19/09. The notification identified the affected product and stated the problem. The letter also advised that users discontinue use of the product and to discard any remaining packages. The attached response form should be completed and returned for replacement of product. If further assistance is needed regarding replacements, customers can contact BD Customer Service Department at 1-800-675-0908.
Quantity in commerce: 144 boxes
Distribution: Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.
Product codes and lots: Lot 8160911, exp June 04, 2009.

Product code KZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)