Blood Culture Kits Recalled Due to Expired Internal Components
Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.
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: FDA Class II medical device recall with expired components that may affect device performance or test result accuracy. No adverse events are mentioned in the recall notice; the hazard is theoretical rather than based on reported injuries or illnesses.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 3,160 units of the 24 Blood Culture Kit (Reference DYNDH1632). The defect is that components within the kits have expired before the overall expiration date indicated on the kit insert.
The affected kits were distributed nationwide in California. The recall includes lot numbers 23EMF710, 23DMF154, and 23DMA779. The product is identified by UDI/DI 40193489916141 (case) and 10193489916140 (unit).
Expired internal components may compromise the device's performance or the reliability of test results. This is a Class II recall issued by the FDA.
The recalled product
- Product
- 24 BLOOD CULTURE KIT, REF DYNDH1632
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Diagnostic
- Hazard
- component-expiration
- test-inaccuracy
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 (4)
- UDI/DI 40193489916141 (case)
- 10193489916140 (unit): Lot Numbers: 23EMF710
- 23DMF154
- 23DMA779
Distribution
Distributed nationwide across the United States.
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