Device product
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Z-0966-2024
Product summary
- Event
- Event 93731
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 500 units
- Official record key
device-enforcement:Z-0966-2024
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 40195327323333 (case), 10195327323332 (unit), Lot Numbers: 23KBH642
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.