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

26–50 of 150

  • 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 they may contain splits or holes that compromise sterility.

    Product
    General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • SevereFDA (Devices)··2016-10-26

    Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri Kit, Kit number PSS1037 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

    Windstone Medical Vein Kit Recall Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 Vein Kits because disposable gloves in the kits may contain splits or holes that compromise sterility.

    Product
    Vein Kit - No Introducer TVS4027-NI(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
    C-Tray Pack, Kit number PSS2707and PSS2707(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 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

    Windstone Medical recalls surgical kits with defective disposable gloves

    Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.

    Product
    Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A 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 Laparoscopic Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,290 laparoscopic kits because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Laparoscopic Pack, Kit number AMS2499 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
  • 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
    Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Custom Venous Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,584 Custom Venous Kits because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(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 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

    Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk

    Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D 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
    Morris Lap Pack, Kit number PSS3199 and PSS3199(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 Surgical Kits

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

    Product
    Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Ortho Minor Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 160 Ortho Minor Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2016-10-26

    Windstone Medical Recalls Lithotomy Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 630 Lithotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room
    Category
    Distribution
    12 states