Z-1056-2020 Class II Terminated
FDA device recall Z-1056-2020 was initiated by Centurion Medical Products Corporation on Dec 11, 2019 and is designated Class II. Reason for recall: Incomplete seals on the sterile package may compromise the sterility The recall status is terminated (terminated Sep 4, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2020
- Initiation Date
- Dec 11, 2019
- Termination Date
- Sep 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1056-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026