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

76–100 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 custom surgical kits.

    Product
    Dr Bragg Vein Tray - RX, kit numbers 007912-5, 007912-6, 007912-7, 007912-8 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Podiatry Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling specific podiatry kits because included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Knee Arthroscopy Kits Recalled for Sterility Compromise

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

    Product
    Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(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
    Total Knee Pack, Kit number AMS4010(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 Basic Face Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,266 Basic Face Kits because the Medtronic gloves included may have splits or holes that compromise sterility.

    Product
    Basic Face Kit, Kit part numbers PS517A(B, PS517A(C, and PS517A(D. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 20 liposuction kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Liposuction Pack, Kit number AMS3323 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 280 Newport Coast Basic Pack surgical kits because the disposable gloves inside may have splits or holes that compromise sterility.

    Product
    Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Bayview Breast Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling Bayview Breast Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 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

    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
    Dr. Harrimans Kit, Kit number PSS3600 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Brow Pack Kits Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling Brow Pack kits because they may contain defective gloves that compromise sterility.

    Product
    Brow Pack, Kit part number PSS1785(A, PSS1785(B, and PSS1785(C. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Medtronic Disposable Surgical 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
    Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. 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 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

    Windstone Medical Packaging Recalls Plastic General Surgery Kits

    Windstone Medical Packaging is recalling 15 Plastic General Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Plastic General Pack, Kit number AMS4215 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
    Custom Arterial Pack, kit number RMS1712(F convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Minor Lithotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 114 Minor Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Minor Lithotomy Pack, Kit number 002650-7 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
    D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(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 surgical kits.

    Product
    C-Birth Pack, Kit part number AMS2037 and AMS2037(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 Arthroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 356 Minor Arthroscopy Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 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 in Laminectomy Kits Recalled for Sterility Risk

    Windstone Medical Packaging is recalling 838 laminectomy kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Arthroscopy Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 5,723 arthroscopy packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(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 Laparotomy Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 230 Laparotomy Kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparotomy Kit, Kit number PSS1036(A and PSS1036(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 is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.

    Product
    Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states