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Recall Observatory FDA recall evidence

Device product

BLOOD CULTURE KIT, REF DYNDH1647B

Z-0314-2024

November 01, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93379
Status
Ongoing
Classification
Class II
Quantity
1890 kits
Official record key
device-enforcement:Z-0314-2024

Official wording

Reason: This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.

Code information: UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954

Distribution pattern: US Nationwide distribution in the state of California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.