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Recall Observatory FDA recall evidence

Device product

MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C

Z-0968-2024

December 21, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93731
Status
Ongoing
Classification
Class II
Quantity
4200 units
Official record key
device-enforcement:Z-0968-2024

Official wording

Reason: 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.

Code information: UDI/DI 40195327509874 (case), 10195327509873 (unit), Lot Numbers: 23JBQ525

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.