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

51–75 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
    Minor Tray AMS2685 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

    Windstone Medical Recalls D & C Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 592 D & C Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    D & C Kit, Kit number CMP1466 and CMP1466(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 they may contain splits or holes that compromise sterility.

    Product
    Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Hall SAP Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 30 Hall SAP surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Hall SAP, Kit number SRK1031(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns

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

    Product
    Abdominoplasty Pack, Kit number AMS3326 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
    Major Ortho Pack, kit number 002647-12 and 002647-13 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
    Port Access Kit, Kit number PSS1505(C 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

    Windstone Medical Packaging Recalls Dr Mullins Surgical Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Laparotomy Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Laparotomy Tray, Kit number PSS1538 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
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Total Joint Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 58 Total Joint Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Total Joint Pack, Kit number 006358-5 and 006358-6 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 GYN-Laparoscopy Tray Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling GYN-Laparoscopy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Cardiac Cath Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 138 Cardiac Cath Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Cardiac Cath Pack, kit number AMS2707 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 Recalls D&C/GYN/Hysteroscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 56 D&C/GYN/Hysteroscopy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    D&C/GYN/Hysteroscopy Pack, Kit number PSS3341 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
    Basic Kit, Part numbers BP1110(C and CMP1109(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 Sterility Compromise in Custom Kits

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

    Product
    Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Minor Ortho Packs Due to Sterility Concerns

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

    Product
    Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Universal Surgery Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Universal Pack, Kit number AMS2036 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 in custom surgical kits.

    Product
    GLBSC Minor Pack, Kit number PSS2644 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
    Bleph Pack, Kit part number AMS3325 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls Major Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 175 Major Kits (PHC1307A) because the Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states