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U.S. Department of Health and Human Services

Class 3 Device Recall BBL Brain Heart Infusion (BHI)

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  Class 3 Device Recall BBL Brain Heart Infusion (BHI) see related information
Date Initiated by Firm February 19, 2009
Date Posted January 15, 2010
Recall Status1 Terminated 3 on February 12, 2010
Recall Number Z-0643-2010
Recall Event ID 53755
Product Classification Enriched Culture Media - Product Code KZI
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.
Code Information Lot 8160911, exp June 04, 2009.
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Kimberly Cartier
410-316-4418
Manufacturer Reason
for Recall		 In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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