The Recall Desk

FDA (Devices) recall action 61848

Stryker Instruments Div. of Stryker Corporation recalled 2 products on 2012-06-20

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2012-06-20
Critical
0
Units
—

Why these products were recalled

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2012-06-20

    Stryker T5 Hytrel Zipper Toga Recalled for Missing Protective Tape

    Stryker is recalling T5 Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2012-06-20

    Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape

    Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Distribution
    39 states