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

1–25 of 150

  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fritsch Pack, Kit number AMS2696 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
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Foot Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Foot Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Foot Pack, Kit number AMS3637 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 Packaging Recalls Student Pack-NS Surgical Kits

    Windstone Medical Packaging is recalling Student Pack-NS surgical kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Student Pack-NS, Kit number PSS2788 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

    Windstone Medical Recalls Lower Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 582 Lower Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. 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 Sterility Compromise in Surgical Kits

    The FDA is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone Medical Packaging facial plastic kits because the gloves may contain splits or holes that compromise sterility.

    Product
    Facial Plastic Pack, Kit numbers AMS2533, AMS2533(A, and AMS3327 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
    Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 1,164 custom surgical kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Plastic Kit, Kit number CMP1084(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. 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

    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

    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
    Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical ENT Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 1,795 ENT surgery kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    ENT Tray, Kit number AMS1195(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Extremity Kits Recalled for Potential Sterility Compromise

    Windstone Medical is recalling 3,829 Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 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
    Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls Mohs Closer Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 340 Mohs Closer Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Dr. Fetters Hand Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fetters Hand Pack, Kit number AMS3690 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

    Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside may contain splits or holes that compromise sterility.

    Product
    Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Cath Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Cath Pack, kit number AMS4283 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 Medtronic gloves inside may have splits or holes, compromising sterility.

    Product
    Major Pack, Kit Number PSS3516 and PSS3516(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
    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

    Windstone Medical Recalls General Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,596 general surgery kits because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    General Pack, Kit numbers: AMS2334, AMS2334(A, AMS2967, AMS2967(A, AMS3239, AMS3709, and AMS3709(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states