Recall Z-1095-2020 ยท PXP Breast Biopsy / Localization Tray
Centurion Medical Products Corporation
Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260 ALCOHOL PREP PACK P928310 WET PREP TRAY P928310 WET PREP TRAY P948416 LACERATION P
| 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.