Medline Blood Culture Tray Adult recalled for incomplete component labeling
Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a documentation/labeling defect and no reported illnesses or injuries. The issue is incomplete documentation of component information, which constitutes a minor labeling error.
Plain-English summary
Medline Industries, LP is recalling specific lots of its Adult Blood Culture Tray (Reorder Number DYNDH1194A) due to incomplete labeling on kit inserts.
The affected kits were manufactured with Bactec components whose lot and expiration date information are not reflected in the product insert. Users may not properly verify the expiration status of the Bactec component inside the kit before use, risking the use of expired components.
The recall affects 2,100 units distributed nationwide. The affected lot is 23JBO540.
Users should check the expiration date on the Bactec component inside each kit before use. Contact Medline Industries for further instructions on replacement or return of affected products.
The recalled product
- Product
- MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 2,100
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 40195327432301 (case)
- 10195327432300 (unit)
- Lot Numbers: 23JBO540
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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