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Recall Observatory FDA recall evidence

Device product

Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y

Z-1083-2020

December 11, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84530
Status
Terminated
Classification
Class II
Quantity
270
Official record key
device-enforcement:Z-1083-2020

Official wording

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

Code information: Lot Code: 2019021190

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