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U.S. Department of Health and Human Services

Class 3 Device Recall Difco (TM) Decarboxylase Base Moeller

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  Class 3 Device Recall Difco (TM) Decarboxylase Base Moeller see related information
Date Initiated by Firm December 09, 2009
Date Posted June 11, 2010
Recall Status1 Terminated 3 on June 14, 2010
Recall Number Z-1787-2010
Recall Event ID 55697
Product Classification Culture media, selective and differential - Product Code JSI
Product Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152***
Code Information Batch No. Exp. Date 9131598 12/13/2013 9055843 12/13/2013 
Recalling Firm/
Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
For Additional Information Contact Kimberly Cartier
Manufacturer Reason
for Recall
Diagnostic test reagents may not meet quality control specifications.
FDA Determined
Cause 2
Action The recalling firm notified distributors by letter flagged as "Urgent Product Recall" on 12/09/09. The letter instructed distributors to discontinue distribution and discard product. Distributors were asked to provide customer lists and the recaller subsequently notified the end users to discontinue and discard identified lots for replacement. Customers were asked to return a response form. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 209 bottles
Distribution The product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.
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.