FDAFDA · Food and drugs·Recall number Z-0964-2024
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Published February 7, 2024 · Recall initiated: December 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution.
- Lot
- UDI/DI 40195327239849 (case), 10195327239848 (unit), Lot Numbers: 23JBM366
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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