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Recall Observatory FDA recall evidence

Device product

Sterile Nail Nipper, Barrel Spring (I68400), Sterile

Z-1720-2019

March 29, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 82667
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1720-2019

Official wording

Reason: Compromised seal on the sterile barrier pouch.

Code information: Lot 2018121101, exp 2023-11-30

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Compromised seal on the sterile barrier