Medline Adult Blood Culture Kits Recalled Due to Unlabeled Component Expiration Dates
Medline is recalling specific Adult Blood Culture Kits because the expiration date of an internal Bactec component is not reflected on the kit insert, creating a risk of using an expired component.
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: This is a risk-of-harm product where no illnesses or injuries have been reported. The hazard is theoretical—expired internal components not labeled on the kit insert—but blood culture kits are critical for infection diagnostics and expired components could compromise test accuracy.
Plain-English summary
Medline Industries, LP is issuing a recall for specific lot numbers of Adult Blood Culture Kits (Reorder Number DYNDH1694A). The affected lot numbers are 23JBH262 and 23JBC264. Approximately 13,860 units have been distributed nationwide in the United States.
The kits were manufactured with a Bactec component whose lot number and expiration date are not reflected on the kit insert. This creates a risk of using an expired component if the user does not check the Bactec component inside the kit for its expiration date.
This recall has been classified as Class II by the FDA.
The recalled product
- Product
- MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- labeling-error
- expired-component
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 40195327139958 (case)
- 10195327139957 (unit)
- Lot Numbers: 23JBH262 and 23JBC264
Distribution
Distributed nationwide across the United States.
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