Class 2 Device Recall BBL Vancomycin Screen Agar

• Date Initiated by Firm: June 29, 2015
• Date Posted: December 23, 2015
• Recall Status: Terminated on August 12, 2016
• Recall Number: Z-0473-2016
• Recall Event ID: 71883
• 510(K)Number: K951539
• Product Classification: Manual antimicrobial susceptibility test systems - Product Code JWY
• Product: Vancomycin Screen Agar
• Code Information: catalog number 222204. Lot numbers 5041659, 5064921, 5076659, 5083712, 5097504, 5105955, 5130907, 5139626, and 5147941
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; BD Diagnostic Systems; 7 Loveton Circle; Sparks MD 21152-0999
• For Additional Information Contact: 410-316-4000
• Manufacturer Reason for Recall: The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.
• FDA Determined Cause: Under Investigation by firm
• Action: Becton Dickinson (BD) sent US customers a Urgent Product Recall letter dated June 2015, via UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. Any product returned to BD will be quarantined and discarded. If further assistance is needed, please contact BD Technical Services at 1-800-638-8663.
• Quantity in Commerce: 60,840
• Distribution: Worldwide Distribution - US (nationwide) Distribution to the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI and WV., and to the countries of : Canada, Colombia, India, Mexico and Europe.
• 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 = JWY