Z-0964-2024 Class II Ongoing
FDA device recall Z-0964-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Dec 21, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 775 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 7, 2024
- Initiation Date
- Dec 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 775 units
Product Description
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 40195327239849 (case), 10195327239848 (unit), Lot Numbers: 23JBM366
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0964-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026