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Recall Observatory FDA recall evidence

Device product

Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF SPEC0265A 22G FACET TRAY SPEC0313 CYST ASPIRATION TRAY-LF SPEC0313 CYST ASPIRATION TRAY-LF

Z-1056-2020

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-1056-2020

Official wording

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

Code information: Lot Numbers: SPEC0002B ARTHROGRAM TRAY 2019032090 SPEC0002B ARTHROGRAM TRAY 2019021890 SPEC0004C ARTHROGRAM TRAY 2019031290 SPEC0071B CUSTOM BX TRAY 2019022590 SPEC0076G STEREO BIOPSY PACK-LF 2019040590 SPEC0122 BASIC BIOPSY TRAY 2019011790 SPEC0130B BREAST BIOPSY TRAY 2019020590 SPEC0158A CT BIOPSY TRAY 2018122090 SPEC0248B GENERAL BIOPSY TRAY- LF 2019012990 SPEC0265A 22G FACET TRAY 2019010290 SPEC0313 CYST ASPIRATION TRAY-LF 2019061290 SPEC0313 CYST ASPIRATION TRAY-LF 2019021290

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