The Recall Desk

FDA (Devices) recall action 71968

Windstone Medical Packaging, Inc. recalled 150 products on 2016-10-26

The FDA (Devices) publishes a recall like this one as 150 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 150 pages.

Products
150
Announced
2016-10-26
Critical
0
Units
104,187

Why these products were recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

126–150 of 150

  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

    Product
    Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves in custom surgical kits because splits or holes may compromise sterility.

    Product
    General Plastic Pack, Kit number PSS2432, PSS2432(A, PSS2717, PSS2717(A, and PSS2717(B. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 985 general surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may compromise sterility.

    Product
    Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 General Pack I surgery kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    General Pack I, Kit number CMP1811(B convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility. The gloves are part of custom surgical kits used in hospitals.

    Product
    DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Basic Surgery Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 6,381 Basic Pack surgery kits because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • SevereFDA (Devices)··2016-10-26

    Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Morris Hysto Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 186 Morris Hysto Pack kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 430 Peri GYN surgical kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Minor Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,025 minor surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • SevereFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls Major Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Major Laparotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • SevereFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Knee Scope Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 272 Knee Scope Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic is recalling disposable gloves used in custom surgical kits because splits or holes may compromise sterility.

    Product
    Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 64 surgical kits because gloves inside may have splits or holes that compromise sterility.

    Product
    Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

    Product
    Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom AMS kits.

    Product
    Bayview Abdominoplasty Pack, Kit part number 009079-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Lap Gallbladder Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Custom Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising sterility.

    Product
    Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states