The Recall Desk

FDA (Devices) recall action 66815

Advanced Sterilization Products recalled 2 products on 2013-12-04

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
2013-12-04
Critical
0
Units
8,762

Why these products were recalled

Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in 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.

1–2 of 2

  • ModerateFDA (Devices)··2013-12-04

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and STERRAD 100NX sterilization systems because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-04

    Advanced Sterilization Products Recalls STERRAD Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX and 100NX sterilizers because bronchoscopes may contain unlisted polyurethane material in the suction channel.

    Product
    STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Distribution
    0 states