The Recall Desk

FDA (Devices) recall action 62925

Advanced Sterilization Products recalled 2 products on 2012-09-19

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
2012-09-19
Critical
0
Units
15,045

Why these products were recalled

Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.

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

  • LowFDA (Devices)··2012-09-19

    Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure

    Advanced Sterilization Products is recalling STERRAD NX cassettes because the camera used to verify printing was disabled, resulting in unverified product labels.

    Product
    STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette…
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2012-09-19

    Advanced Sterilization Products Recalls STERRAD 100S and NX Cassettes

    Advanced Sterilization Products is recalling STERRAD 100S and NX cassettes because a camera used to verify printing was disabled, resulting in unverified product labels.

    Product
    STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette…
    Category
    Distribution
    0 states