BEUDAMED
    FDA Enforcement Class II Terminated

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    Recall: Z-1134-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1134-2019
    Event ID
    82420
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    March 12, 2019
    Classification Date
    April 12, 2019
    Termination Date
    July 17, 2020
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO

    Reason

    VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

    Code Info

    Product Name/Product Code/Lot Numbers: VICRYL SUTURE 18"(45CM) 0 VIO D6043 MKM683, ML5314 VICRYL SUTURE 18"(45CM) 2-0 UND D6226 MJM912 VICRYL SUTURE 18"(45CM) 0 VIO J701D MJ6796 VICRYL SUTURE 18"(45CM) 3-0 VIO J713D MGK411 VICRYL SUTURE 18"(45CM) 4-0 UND J714D ME5059 MKM907 VICRYL SUTURE 18"(45CM) 2-0 VIO J726D ME5454 VICRYL SUTURE 18"(45CM) 0 VIO J727D MHZ777 VICRYL SUTURE 18"(45CM) 2-0 VIO J739D MGZ324 MHM399 VICRYL CT VIO 8X18IN 0 S/A CT-1 CR 740D ME6539 MJM523 VICRYL SUTURE 18"(45CM) 1 VIO J741D MGZ624 MJ5193 VCL CT UD 8X18IN 2-0 S/A CP-2 CR J762D MJZ094 MLZ026 VCL CT VIO 8X18IN 3-0 S/A SH-1 CR J772D MHZ196 VICRYL CT VIO 8X18IN 2-0 S/A SH CR J775D MLZ864 VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR J839D MG2349 MG2593 MG2666 MG7585 MK2820 VICRYL CT UD 8X18IN 0 S/A CT-1 CR J840D MEK770 MGK812 MJK773 MM6633 VCL CT UD 8X18IN 1 S/A CT-1 CR J841D MEK194 MGK749 MMM998 VCL CT UD 8X18IN 3-0 S/A SH CR J864D MEK524 MGZ556 MHZ379 MHZ475 MJK262 VICRYL SUTURE 18"(45CM) 0 UND JB840 MEK959 MGM275 MGM643 MM6544 VICRYL CT VIO 8X27IN 0 S/A CT-1 CR JJ31G MJK828 VICRYL SUTURE 27"(70CM) 1 UND JJ40G ME6809 VICRYL CT UD 8X27IN 0 S/A CT-1 CR JJ41G ME5281 MGZ466 MGZ563 MHK212 VICRYL SUTURE 27"(70CM) 0 VIO JJ81G MKK878

    Distribution

    Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE

    Quantity

    550,681 eaches (WW) Total