Medline Blood Culture Kits recalled for inaccurate expiration dating
Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.
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: FDA Class II recall involving a labeling discrepancy on kit insert materials. No illnesses or injuries have been reported, and the hazard is theoretical and avoidable through direct inspection of the component itself.
Plain-English summary
Medline Industries, LP is recalling specific lots of its Blood Culture Kits due to a labeling discrepancy. The kits contain a Bactec component with an expiration date, but this expiration date is not accurately documented on the kit insert materials.
The recall affects approximately 4,200 units with lot number 23JBQ525 that were distributed nationwide in the United States. The kits in question were assembled using Bactec components whose expiration dates do not match the information provided in the kit insert.
The risk is that users could unknowingly use an expired Bactec component if they do not independently verify the expiration date by examining the component itself. Using an expired component could result in inaccurate or unreliable blood culture test results.
Consumers and healthcare facilities should check the expiration date printed directly on the Bactec component before use. Any kits containing expired components should not be used. Contact Medline Industries for replacement or return instructions.
The recalled product
- Product
- MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 4,200
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 (3)
- UDI/DI 40195327509874 (case)
- 10195327509873 (unit)
- Lot Numbers: 23JBQ525
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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