The Recall Desk

FDA (Devices) recall action 76280

Windstone Medical Packaging, Inc. recalled 124 products on 2017-03-08

The FDA (Devices) publishes a recall like this one as 124 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 124 pages.

Products
124
Announced
2017-03-08
Critical
0
Units
42,406

Why these products were recalled

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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 124

  • HighFDA (Devices)··2017-03-08

    Windstone Medical Packaging Recalls Podiatry Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 2,018 Podiatry Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 331 laparotomy packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Knee Scope Packs Recalled for Sterility Compromise

    Windstone Medical Packaging is recalling 156 Knee Scope Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Packaging Recalls Open Procedure Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,125 Open Procedure Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Recalls Vascular Packs Due to Sterility Compromise

    Windstone Medical Packaging is recalling 360 Vascular Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise

    Windstone Medical Packaging recalled 35 liposuction kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction Pack, part number AMS5699
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Packaging Recalls Shoulder Packs with Defective Gloves

    Windstone Medical Packaging is recalling 875 Shoulder Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Recalls Anterior Cervical Fusion Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 51 Anterior Cervical Fusion Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Recalls General Laparoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 36 General Laparoscopy Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2017-03-08

    Windstone Medical Recalls Extremity Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 810 Extremity Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity…
    Category
    Distribution
    26 states