FDAClass IINovember 22, 2023

Blood Culture KIT recall

BLOOD CULTURE KIT, REF DYNDH1647B

Why was Blood Culture KIT recalled?

This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954

Product
BLOOD CULTURE KIT, REF DYNDH1647B
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1890 kits
Distribution
US Nationwide distribution in the state of California.
Recall date
November 22, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls