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Recall Observatory FDA recall evidence

Device product

Namic FLUID DELIVERY SET, REF 91300040

Z-1807-2024

March 12, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94313
Status
Ongoing
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1807-2024

Official wording

Reason: Products have a lack of sterility assurance.

Code information: UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381

Distribution pattern: US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    lack of sterility