Z-0110-2024Class II

BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

Name: Z-0110-2024 BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Creator: Becton Dickinson & Co.
Published: 2023-09-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2023-09-12 / Open, Classified / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 on 2023-09-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0110-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-12
Posted: 2023-10-12
Recalling firm: Becton Dickinson & Co
Product: BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Product code: MDB System, Blood Culturing
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.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: UDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0110-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0110-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

Product code MDB

K113558Class IBD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company / cleared 2012-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)