Skip to content
Recall Observatory FDA recall evidence

Device product

Centurion- I86625 DEBRIDEMENT TRAY

Z-1081-2020

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-1081-2020

Official wording

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

Code information: Lot Code: 2019040590, 2018111690

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