FDAClass IIFebruary 7, 2024

Medline Adult Blood Culture KIT recall

MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A

Why was Medline Adult Blood Culture KIT recalled?

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.

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 40195327139958 (case), 10195327139957 (unit), Lot Numbers: 23JBH262 and 23JBC264

Product
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
13860 units
Distribution
US Nationwide distribution.
Recall date
February 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls