FDA Recall Terminated

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.

Recall: Z-0643-2010 · Initiated February 19, 2009

Recall

Recall Number
Z-0643-2010
Event Number
53755
Firm
Becton Dickinson & Co.
FEI Number
1119779
Product Code
KZI
Status
Terminated
Root Cause
Equipment maintenance
Initiated
February 19, 2009
Posted
January 15, 2010
Terminated
February 12, 2010
Address
7 Loveton Cir, Sparks, MD, 21152-9212

Description

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.

Reason

In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.

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.

Distribution

Nationwide Distribution -- Including states of CA, CO, FL, GA, IL, MI, MN, MT, NY, OH, PA, TN, TX, UT, and VA.

Quantity

144 boxes