MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
FDA Recall #Z-0965-2024 — Class II — December 21, 2023
Product Description
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4320 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 40195327347551 (case), 10195327347550 (unit), Lot Numbers: 23KBC138
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated