Blood culture kit recalled due to expired internal components
Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.
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 an FDA Class II medical device recall where internal components have expired before the overall expiration date, creating a risk of compromised diagnostic function. No illnesses, injuries, or deaths have been reported.
Plain-English summary
Medline Industries, LP is recalling 1,890 units of BLOOD CULTURE KIT, REF DYNDH1647B.
The kit is being recalled because components within the kit have expired before the kit's overall expiration date as stated on the insert. Expired materials may compromise the kit's ability to function properly for diagnostic blood culture testing.
The affected lot numbers are 23CMH028 and 23CMD954. The kits were distributed nationwide within California. Healthcare facilities and laboratories using these kits should immediately discontinue use and contact Medline Industries for replacement units and further guidance.
The recalled product
- Product
- BLOOD CULTURE KIT, REF DYNDH1647B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Diagnostics
- Hazard
- expired-materials
- diagnostic-accuracy
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 40195327267002 (case)
- 10195327267001 (unit): Lot Numbers: 23CMH028
- 23CMD954
Distribution
Distributed nationwide across the United States.
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