Class 2 Device Recall BD BBL Gram Crystal Violet 250mL

• Date Initiated by Firm: April 14, 2020
• Create Date: May 19, 2020
• Recall Status: Terminated on February 10, 2022
• Recall Number: Z-2046-2020
• Recall Event ID: 85508
• Product Classification: Stains, microbiologic - Product Code JTS
• Product: BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
• Code Information: Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: SAME; 410-316-4000
• Manufacturer Reason for Recall: May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
• FDA Determined Cause: Under Investigation by firm
• Action: BD issued Urgent Medical Device Notification to Customers/Distributors on 4/14/20 via FedEX stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated above. Distributors requested to provide customer list to BD. BD will provide a product replacement for all discarded inventory. BD Customer/Technical Support 800-638-8663, Monday  Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the United States, contact your local BDrepresentative or distributor. On 5/12/20 firm expanded the recall to an additional six (6) lots of product.
• Quantity in Commerce: 10,568 bottles
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
• 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.