Class 3 Device Recall BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA

• Date Initiated by Firm: November 11, 2009
• Date Posted: March 08, 2010
• Recall Status: Terminated on May 13, 2010
• Recall Number: Z-1008-2010
• Recall Event ID: 53961
• 510(K)Number: K921133
• Product Classification: system, blood culturing - Product Code MDB
• Product: BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***; ; BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
• Code Information: 9233240 exp 6/30/2010 9233261 exp 6/30/2010 9233263 exp 6/30/2010 9257241 exp 6/30/2010 9257242 exp 6/30/2010 9257243 exp 6/30/2010 9257245 exp 6/30/2010 9267148 exp 7/31/2010 9267150 exp 7/31/2010 9267151 exp 7/31/2010 9267152 exp 7/31/2010 9267153 exp 7/31/2010 9267154 exp 7/31/2010 9267155 exp 7/31/2010 9267156 exp 7/31/2010 9267161 exp 7/31/2010 9267163 exp 7/31/2010 9267165 exp 7/31/2010 9267167 exp 7/31/2010 9267169 exp 7/31/2010 9267171 exp 7/31/2010 9268355 exp 7/31/2010 9268356 exp 7/31/2010 9299501 exp 8/31/2010
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: BD Technical Services; 800-638-8663
• Manufacturer Reason for Recall: The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.
• FDA Determined Cause: Component change control
• Action: An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when used as instructions indicate. The customers are being urged to pay close attention to their BACTEC blood collection procedure until they receive bottles with the revised labels. Drawing too much blood may contribute to false negative or false positive results. The customer is being ask to communicate this information to all specimen collection sites within their facility. If further assistance is needed, please contact BD Technical Services Department at 1-800-638-8663.
• Quantity in Commerce: 2,940,473 bottles
• Distribution: Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay
• 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 = MDB and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC