FDA recall Z-1095-2020

Centurion Medical Products Corporation · Class II · device

Product

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 PACK P966455A BREAST BIOPSY PACK-LF

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

Distribution

Nationwide Foreign: GHANA

Key facts

Status
Terminated
Initiation date
2019-12-11
Report date
2020-02-12
Termination date
2020-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Williamston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2020