FDA Enforcement Class II Terminated

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

Recall: Z-1095-2020 · Reported February 12, 2020

Enforcement

Recall Number: Z-1095-2020
Event ID: 84530
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: Centurion Medical Products Corporation
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: February 12, 2020
Initiation Date: December 11, 2019
Classification Date: February 5, 2020
Termination Date: September 4, 2020
Address: 100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

Description

Reason

Incomplete seals on the sterile package may compromise the sterility

Code Info

Product/Lot Number: P151659 BIOPSY TRAY 2019031490 P243133 LATEX TUBING PACK 2019042590 P243133 LATEX TUBING PACK 2019031990 P243133 LATEX TUBING PACK 2019022190 P261569 PACK BIOPSY 2019021490 P392929 BMT-LACERATION PACK 2018121790 P429589A TRAY BONE MARRO ASC LTX SAFE 2019012590 P734457 SUTURE REMOVAL PACK LATEX SAFE 2019031990 P751651A BIOPSY PROCEDURE PACK 2019020890 P758486 PVP PREP PACK 2019041590 P758486 PVP PREP PACK 2019031990 P922260 ALCOHOL PREP PACK 2019041580 P928310 WET PREP TRAY 2019050690 P928310 WET PREP TRAY 2019031590 P948416 LACERATION PACK 2018110990 P966455A BREAST BIOPSY PACK-LF 2018122790

Distribution

Nationwide Foreign: GHANA

Quantity

N/A