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U.S. Department of Health and Human Services

Class 2 Device Recall BBL(TM) Fildes Enrichment

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  Class 2 Device Recall BBL(TM) Fildes Enrichment see related information
Date Initiated by Firm December 10, 2012
Date Posted January 25, 2013
Recall Status1 Terminated 3 on July 01, 2013
Recall Number Z-0739-2013
Recall Event ID 64008
Product Classification Culture media, general nutrient broth - Product Code JSC
Product BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA***

Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.
Code Information Lot/Exp 2079066/ EXP March 6, 2013 2096375/ EXP March 22, 2013 2216092/ EXP July 20, 2013 2227271/ EXP Auqust 2, 2013 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Ms. Gail Claiborne
410-316-4000
Manufacturer Reason
for Recall		 Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Becton Dickinson sent an Urgent Product Recall letter dated December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to discontinue use and discard any remaining product for replacement. Customers were also advised that due to an anticipated extended delay for the availability of Fildes Enrichment, BD will substitute DIFCO" Supplement B with Reconstituting Fluid as the replacement product. Customers were advised to ensure that this replacement product is appropriately validated in accordance with their laboratory's procedures. Customers with questions should contact BD Technical Services Department at 1-800-638-8663. For questions regarding this recall call 410-316-4000.
Quantity in Commerce 11,710 tubes
Distribution Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.
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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