The Recall Desk

FDA (Devices) recall action 71209

Advanced Sterilization Products recalled 2 products on 2015-06-17

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
2015-06-17
Critical
0
Units
869

Why these products were recalled

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.

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

  • HighFDA (Devices)··2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to a
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner for Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, allowing the cleaning cycle to complete without proper processing.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve c
    Category
    Distribution
    0 states