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U.S. Department of Health and Human Services

Class 2 Device Recall CDC Anaerobe 5 Sheep Blood Agar

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  Class 2 Device Recall CDC Anaerobe 5 Sheep Blood Agar see related information
Date Initiated by Firm June 06, 2014
Date Posted January 14, 2015
Recall Status1 Terminated 3 on August 12, 2016
Recall Number Z-0975-2015
Recall Event ID 69091
510(K)Number K803025  
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product CDC Anaerobe 5% Sheep Blood Agar

CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.
Code Information Catalogue # 221734 with Lot #4077423
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4000
Manufacturer Reason
for Recall		 A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.
Quantity in Commerce 1,530 cases (100 plates/case)
Distribution Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
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.
510(K) Database 510(K)s with Product Code = JSG and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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