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U.S. Department of Health and Human Services

Class 2 Device Recall Gram Crystal Violet 250 mL

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  Class 2 Device Recall Gram Crystal Violet 250 mL see related information
Date Initiated by Firm April 12, 2012
Date Posted July 18, 2012
Recall Status1 Terminated 3 on December 10, 2012
Recall Number Z-2032-2012
Recall Event ID 61769
Product Classification Stains, microbiologic - Product Code JTS
Product Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles.

Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Code Information Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013
Recalling Firm/
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Gail Claiborne
Manufacturer Reason
for Recall
Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
FDA Determined
Cause 2
Material/Component Contamination
Action BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 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 the affected product. An Acknowledgement Form was attached for customers to complete and return via fax to 410-316-4258. Contact the BD Customer Service Department for questions regarding this recall.
Quantity in Commerce 878 cartons/ 3512 bottles
Distribution Nationwide Distribution.
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.