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Recall Observatory FDA recall evidence

Device product

Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990

Z-1079-2020

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-1079-2020

Official wording

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

Code information: Product-Lot Code: GR100150ST GRADUATED PITCHER STERILE 1000 CC 2018121090 GR1200ST STERILE 1200CC PITCHER KIT 2019031990

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