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Recall Observatory FDA recall evidence

Device product

Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE INSERTION TRAY CHT940 CHEST TUBE INSERTION TRAY

Z-1043-2020

December 11, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
Event
Event 84530
Status
Terminated
Classification
Class II
Quantity
448
Official record key
device-enforcement:Z-1043-2020

Official wording

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

Code information: Kit Code Product Lot Number CHT1170 CHEST TUBE TRAY 2019011690 CHT1700 CHEST TUBE INSERTION TRAY 2018111490 CHT1760 CHEST TRAY 2019031490 CHT275 CHEST TUBE INSERTION TRAY 2019050890 CHT440 CHEST TUBE INSERTION TRAY 2019050690 CHT701 CHEST TUBE INSERTION TRAY 2019012590 CHT760 CHEST TUBE INSERTION TRAY 2018110890 CHT940 CHEST TUBE INSERTION TRAY 2019010290

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