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Recall Observatory FDA recall evidence

Device product

Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION

Z-1059-2020

December 11, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84530
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1059-2020

Official wording

Reason: Incomplete seals on the sterile package may compromise the sterility

Code information: Lot Numbers: 2019050190, 2019011790

Distribution pattern: Nationwide Foreign: GHANA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seals on the sterile package may compromise the sterility