Class 2 Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar

• Date Initiated by Firm: March 28, 2016
• Date Posted: April 22, 2016
• Recall Status: Terminated on November 14, 2016
• Recall Number: Z-1559-2016
• Recall Event ID: 73783
• Product Classification: Culture media, selective and differential - Product Code JSI
• Product: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
• Code Information: Cat. Number Lot Number 221291 6034889
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; BD Diagnostic Systems; Sparks MD 21152-9212
• For Additional Information Contact: 410-316-4000
• Manufacturer Reason for Recall: Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
• FDA Determined Cause: Material/Component Contamination
• Action: BD sent an Urgent Product Recall letter dated March 2016 to all US customers via UPS or email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected lots and discard any remaining product. BD will replace the discard inventory. Customers were asked to complete and fax the attached form to : Attention Regulatory Compliance, Fax: 410-316-4258 or email to BDRC2@bd.com.
• Quantity in Commerce: 88,300 plates (883 cartons)
• Distribution: US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
• 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.