Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recalled blood culture kits contain a diagnostic component whose expiration date is not disclosed on the kit insert, creating a risk that users could unknowingly use expired medical testing material and obtain inaccurate results. Although no incidents have been reported, this qualifies as a risk-of-harm product with potential for serious diagnostic failure.
Plain-English summary
Medline Industries, LP is recalling specific lots of MEDLINE BLOOD CULTURE KIT (Reorder Number DYNDH1723). The recall affects 960 units with lot number 23JBO541 that were distributed nationwide in the United States.
The kits were assembled using a Bactec component that has its own lot number and expiration date. This component information was not included on the kit's insert documentation. Users who rely on the kit insert alone will not be aware of the Bactec component's expiration date.
There is a risk that users may unknowingly use an expired component if they do not manually check the Bactec inside the kit for its expiration date. An expired component could compromise the accuracy of blood culture testing.
Users should check the Bactec component inside the kit for its expiration date before use. Anyone in possession of a kit with lot number 23JBO541 should contact Medline Industries for instructions on returning or replacing the product.
The recalled product
- Product
- MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- expired-component
- labeling-error
- diagnostic-failure
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 40195327134205 (case)
- 10195327134204 (unit)
- Lot Numbers: 23JBO541
Distribution
Distributed nationwide across the United States.
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