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U.S. Department of Health and Human Services

Class 2 Device Recall GasPak EZ Large Incubation Container

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  Class 2 Device Recall GasPak EZ Large Incubation Container see related information
Date Initiated by Firm August 13, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-0480-2011
Recall Event ID 57023
Product Classification Device, gas generating - Product Code KZJ
Product GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***
Code Information Batch No. 7110573
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kimberly Cartier
410-316-4418
Manufacturer Reason
for Recall		 In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form. BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663.
Quantity in Commerce 496 units
Distribution Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,
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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