BEUDAMED
    FDA Enforcement Class II Terminated

    AVANOS MIC-KEY SF Gastrostomy Feeding Tube

    Recall: Z-2969-2020 · Reported September 23, 2020

    Enforcement

    Recall Number
    Z-2969-2020
    Event ID
    86244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 23, 2020
    Initiation Date
    July 29, 2020
    Classification Date
    September 14, 2020
    Termination Date
    January 31, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    AVANOS MIC-KEY SF Gastrostomy Feeding Tube

    Reason

    Devices had cracked or detached from the feeding tube body

    Code Info

    REF Product Code: 7120-12-1.0; Size 12Fr, 1.0 cm; Lot # 30041194 REF Product Code: 7120-12-1.7; Size: 12Fr, 1.7 cm; Lot # 30039482 REF Product Code: 7120-12-4.5; Size: 12Fr, 4.5cm; Lot # 30057268 REF Product Code: 7120-14-0.8; Size:14Fr, 0.8cm; Lot # 30020939 REF Product Code: 7120-14-1.0; Size: 14Fr, 1.0cm; Lot # 30012320, 30020940 REF Product Code: 7120-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020941, 30046143 REF Product Code: 7120-14-1.5; Size: 14Fr, 1.5cm; Lot # 30012322, 30027259 REF Product Code: 7120-14-1.7; Size: 14Fr, 1.7cm; Lot # 30012323 REF Product Code: 7120-14-2.0; Size:14Fr, 2.0cm; Lot # 30012326, 30018098 REF Product Code: 7120-14-2.3; Size: 14Fr, 2.3cm; Lot # 30018099 REF Product Code: 7120-14-2.5; Size: 14Fr, 2.5cm; Lot # 30012328 REF Product Code: 7120-14-2.7; Size: 14Fr, 2.7cm; Lot # 30012324 REF Product Code: 7120-14-3.0; Size: 14Fr, 3.0cm; Lot # 30012327 REF Product Code: 7120-14-3.5; Size: 14Fr, 3.5cm; Lot # 30041187 REF Product Code: 7120-16-5.5; Size: 16Fr, 5.5cm; Lot # 30046156 REF Product Code: 7140-12-1.5; Size: 12Fr, 1.5cm; Lot # 30015733 REF Product Code: 7140-14-0.8; Size: 14Fr, 0.8cm; Lot # 30020938 REF Product Code: 7140-14-1.0; Size: 14Fr, 1.0cm; Lot # 30072145, 30020061 REF Product Code: 7140-14-1.2; Size: 14Fr, 1.2cm; Lot # 30020062 REF Product Code: 7140-14-1.5; Size: 14Fr, 1.5cm; Lot # 30020063 REF Product Code: 7140-14-1.7; Size: 14Fr, 1.7cm; Lot # 30020064, 30049920 REF Product Code: 7140-14-2.0; Size: 14Fr, 2.0cm; Lot # 30020065 REF Product Code: 7140-14-2.3; Size: 14Fr, 2.0cm; Lot # 30020066 REF Product Code: 7140-14-2.5; Size: 14Fr, 2.5cm; Lot # 30020067 REF Product Code: 7140-14-3.5; Size: 14Fr, 3.5cm; Lot # 30021846 REF Product Code: 7140-14-4.0; Size: 14Fr, 4.0cm; Lot # 30021847 REF Product Code: 7140-14-4.5; Size: 14Fr, 4.5cm; Lot # 30021848 REF Product Code: 7140-14-5.0; Size: 14Fr, 5.0cm; Lot # 30044458 REF Product Code: 7140-16-1.0; Size: 16Fr, 1.0cm; Lot # 30058995 REF Product Code: 7140-16-1.5; Size: 16Fr, 1.5cm; Lot # 30021429 REF Product Code: 7140-16-2.3; Size: 16Fr, 2.3cm; Lot # 30021432, 30057743 REF Product Code: 7140-16-2.5; Size: 16Fr, 2.5cm; Lot # 30052745 REF Product Code: 7140-18-2.3; Size: 18Fr, 2.3cm; Lot # 0002968773 REF Product Code: 7140-18-5.5; Size: 18Fr, 5.5cm; Lot # 30052898 REF Product Code: 7140-20-2.0; Size: 20Fr, 2.0cm; Lot # 30054211

    Distribution

    US states: OK IL WI PA TX IL PA NJ OK LA OUS: Belgium

    Quantity

    284 units