Class 2 Device Recall BD BBL Trypticase Soy Agar with 5 Sheep Blood, Catalog No. 221261

• Date Initiated by Firm: October 22, 2018
• Date Posted: November 30, 2018
• Recall Status: Terminated on April 03, 2020
• Recall Number: Z-0528-2019
• Recall Event ID: 81572
• Product Classification: Culture media, non-selective and non-differential - Product Code JSG
• Product: BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
• Code Information: UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Distributors were notified via email on October 22, 2018, requesting their customer distribution list. Customer letters were sent via UPS beginning on October 29, 2018. **Distributors are Advised to do the following: 1.Discard any remaining inventory of the above referenced product. 2.Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. 3.Within three days, provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from your distribution branches so we may inform them of this issue. Fax or email to: BD Regulatory Compliance Fax: 410-316-4258 Email: BDRC2@bd.com 4.A copy of the customer communication is attached for your records. **Customers area Advised to Take the Following Action(s): 1. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Discard any remaining inventory of lot 8221508. BD will process replacement of any discarded inventory upon receipt of the Customer Response Form. 3. Share a copy of the Recall Letter with all users of the product within your facility to ensure awareness. Customers with questions may call 800-638-8663, Monday through Friday 7 am - 7 pm, EST.
• Quantity in Commerce: 54,300 plates
• Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV
• 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.