The Recall Desk

FDA (Devices) recall action 64692

Advanced Sterilization Products recalled 2 products on 2013-04-10

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
2013-04-10
Critical
0
Units
2,538

Why these products were recalled

The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

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.

1–2 of 2

  • ModerateFDA (Devices)··2013-04-10

    Advanced Sterilization Products Recalls STERRAD 200 Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD 200 Sterilization Systems because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-04-10

    Advanced Sterilization Products Recalls STERRAD 100NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD 100NX Sterilization Systems because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical…
    Category
    Distribution
    0 states