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U.S. Department of Health and Human Services

Class 2 Device Recall Fildes Enrichment

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 Class 2 Device Recall Fildes Enrichmentsee related information
Date Initiated by FirmFebruary 20, 2012
Date PostedMarch 23, 2012
Recall Status1 Terminated 3 on June 18, 2012
Recall NumberZ-1282-2012
Recall Event ID 61305
Product Classification Culture media, general nutrient broth - Product Code JSC
ProductFildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 21030. Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms.
Code Information Lot 1186346, exp June 22, 2012 Lot 1229762, exp August 03, 2012
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information ContactKim Cartier
410-316-4418
Manufacturer Reason
for Recall		In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBecton Dickinson (BD) sent an "URGENT PRODUCT RECALL" letter dated February 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard any remaining affected product. BD will issue replacements for the discarded product. Additionally, an Acknowledgment Form was attached for customers to complete and return to the firm via fax to 410-316-4258. Contact BD Technical Services Department for questions regarding this notice.
Quantity in Commerce6930 tubes
DistributionWorldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Japan, Mexico, and Taiwan.
Total Product Life CycleTPLC 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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