The Recall Desk

FDA (Devices) recall action 67043

Advanced Sterilization Products recalled 3 products on 2014-01-22

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2014-01-22
Critical
0
Units
8,183

Why these products were recalled

Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

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.

1–3 of 3

  • ModerateFDA (Devices)··2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odor Reports

    Advanced Sterilization Products is recalling STERRAD 50, NX, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-01-22

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems Due to Odors

    Advanced Sterilization Products is recalling STERRAD NX, 50, and 100S sterilization systems because healthcare workers detected odors possibly emanating from the devices.

    Product
    STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.
    Category
    Distribution
    0 states