Medline Blood Culture Collection Kits Recalled for Expired Internal Components
Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.
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 involving a product defect where internal components are expired despite the kit's stated expiration date. This creates a risk of compromised sterility in a critical diagnostic device. No illnesses or injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling 4,850 adult blood culture collection kits (model ADLT BLOOD CULTURE COLLECT KIT, Reference DYNDH1245). The affected kits include lot numbers 23EMI373, 23EMF712, 23DMF155, and 23CMH026.
The recall was issued because components contained within the kit have expired before the overall kit expiration date printed on the insert. This discrepancy means users relying on the insert's expiration date may inadvertently use expired components, potentially compromising the sterility or function of the collection process.
The kits were distributed nationwide with distribution noted in California. Blood culture collection kits are used by healthcare facilities to collect blood samples for diagnostic testing.
The recalled product
- Product
- ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- expired-components
- sterility-risk
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 (5)
- UDI/DI 40889942604723 (case)
- 10889942604722 (unit): Lot Numbers: 23EMI373
- 23EMF712
- 23DMF155
- 23CMH026
Distribution
Distributed nationwide across the United States.
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