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BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number… recallZ-0110-2024 · Becton Dickinson & Co. · initiated Sep 12, 2023

Class II Open, Classified All recalls posted in October 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0110-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Sep 12, 2023
Posted by the FDA
Oct 12, 2023
Recalling firm
Becton Dickinson & Co.
Quantity
781,600 vials
Product code
MDB
FDA submissions
K113558
Distribution
Worldwide - US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488

Other devices under the same FDA submission

1 device cleared under K113558 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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