BD BACTEC Plus Aerobic/F Culture Vials Recalled for Duplicate Barcode Labels
BD is recalling certain lots of BACTEC Plus Aerobic/F Culture Vials because some vials have duplicate barcode sequence numbers on their labels. The recall affects 781,600 vials distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a labeling error with no reported injuries, illnesses, or direct patient safety hazard. Duplicate barcode numbers are a minor identification/tracking issue that affects laboratory operations rather than the product's medical function, consistent with the rubric category of 'minor labeling errors.'
Plain-English summary
Becton Dickinson & Co. is recalling certain lots of BD BACTEC Plus Aerobic/F Culture Vials (Catalog Number 442023) due to a labeling defect. The affected vials contain duplicate barcode sequence numbers printed on their labels. The recall involves lot numbers 3062843, 3062846, 3062849, 3062847, 3067489, and 3067488.
Culture vials are used in clinical laboratory settings to collect and identify microbial samples for diagnostic testing. Duplicate barcode sequence numbers could create identification or tracking issues when vials are processed through laboratory information systems. The recalled vials were distributed worldwide with US nationwide distribution affecting approximately 781,600 units.
Healthcare facilities and clinical laboratories using these products should immediately discontinue use of the identified lot numbers. Institutions should contact Becton Dickinson & Co. directly for replacement vials or consult the FDA recall notice for further instructions. No injuries or illnesses have been reported in connection with this labeling issue.
The recalled product
- Product
- BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 781,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 038290HXRPGWNNMN
- Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488
Distribution
Distributed nationwide across the United States.
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