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.
FDA Recall Z-0643-2010 · Posted 2010-01-15
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeKZI
Date Initiated2009-02-19
Date Terminated2010-02-12
Product Quantity144 boxes
Reason for Recall
In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.