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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 1,890
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
Part of a larger recall action
This product is one of 5 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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