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Recall Observatory FDA recall evidence

Device product

Centurion-Suture Tray DYNDR1210A SUTURING TRAY

Z-1075-2020

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-1075-2020

Official wording

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

Code information: Product-Lot Code: DYNDR1210A SUTURING TRAY 2019031290

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