Class 2 Device Recall CDC Anaerobe 5 Sheep Blood Agar

• Date Initiated by Firm: June 06, 2014
• Date Posted: January 14, 2015
• Recall Status: Terminated 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: 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