FDA recall Z-1057-2020

Product

Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT11515 LACERATION TRAY SUT11540A LACERATION TRAY SUT11590 SUTURE SET SUT11775 LACERATION TRAY SUT11780 MINOR TRAY SUT1189B LACERATION TRAY SUT11900 SUTURE TRAY SUT11910 LACERATION TRAY SUT11965 SUTURE SET SUT11970 SUTURE TRAY SUT12025 LACERATION TRAY SUT12225 SUTURE TRAY REGULAR SUT12275 SUTURING SET SUT12335 LACERATION TRAY SUT12625 SNAGFREE LACERATION TRAY SUT12765 SNAGFREE LACERATION TRAY SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12895 SUTURE SET SUT12970 PLASTIC TRAY SUT13315 LACERATION TRAY SUT13400 SNAG FREE PLASTICS TRAY W/OR INSTRUMENTS SUT13510 LACERATION TRAY SUT13535 PLASTICS SUTURE TRAY SUT13550 LACERATION TRAY SUT13555 SUTURE TRAY SUT13620 LACERATION TRAY SUT13620 LACERATION

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-1057-2020