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Recall Observatory FDA recall evidence

Device product

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

Z-0110-2024

September 12, 2023

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 93097
Status
Ongoing
Classification
Class II
Quantity
781,600 vials
Official record key
device-enforcement:Z-0110-2024

Official wording

Reason: 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.

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

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.