The Recall Desk

FDA (Devices) recall action 69692

Advanced Sterilization Products recalled 5 products on 2014-12-31

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-12-31
Critical
0
Units
—

Why these products were recalled

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

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

1–5 of 5

  • ModerateFDA (Devices)··2014-12-31

    Advanced Sterilization Products Recalls STERRAD 100S Cassettes for Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 100S cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-31

    Advanced Sterilization Products Recalls STERRAD 50 Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 50 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-31

    Advanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD System cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-31

    Advanced Sterilization Products Recalls STERRAD 200 Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 200 cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-12-31

    Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Defect

    Advanced Sterilization Products is recalling STERRAD 100NX cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.

    Product
    STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states