Class 2 Device Recall BD BACTEC Plus Aerobic/F Culture Vials

• Date Initiated by Firm: September 12, 2023
• Date Posted: October 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0110-2024
• Recall Event ID: 93097
• 510(K)Number: K113558
• Product Classification: System, blood culturing - Product Code MDB
• Product: BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
• Code Information: UDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: Medical Device Product Correction notification letter dated 9/12/23 was sent to customers. Please Take the Following Actions: 1. Immediately inspect your inventory for the specific catalog and lot numbers listed above to determine if the BD BACTEC" Plus Aerobic/F Culture Vials in your possession are impacted. 2. Ensure the contents of this Product Advisory are read and understood. 3. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 4. Users should verify that the accession number on the BD BACTEC" Instrument loading screen matches the vial's accession number while scanning and loading onto the instrument. If an error message or other system action occurs when loading vials into the BD BACTEC" Instrument that indicates a potential issue with duplicate sequence numbers, it is recommended to follow the instructions within the message and to view the table of System Alerts located in 7 Troubleshooting of the BD BACTEC" FX Instrument User s Manual before taking any further action in vial processing. The URL link to access the BD BACTEC" FX Instrument User s Manual is noted below. There are no additional follow-up activities recommended for patient samples processed. https://eifu.bd.com/en/search/search-results?term=441385&cats=9444_9445,9441_9443,9441_9442,1185_1206,1185 5. 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 per FDA requirements. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 Distributors Please Ta
• Quantity in Commerce: 781,600 vials
• Distribution: Worldwide - US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MDB and Original Applicant = Becton, Dickinson and Company