Recall Z-1056-2020 ยท PXP Breast Biopsy / Localization Tray
Centurion Medical Products Corporation
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
| Date | Dec 11, 2019 |
| Status | Terminated |
| Reason | Incomplete seals on the sterile package may compromise the sterility |
| Root cause | Packaging process control |
| Action | Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Pleas |
| Distribution | Nationwide Foreign: GHANA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.