Home / Recalls / Advanced Sterilization Products / Z-1715-2015

Z-1715-2015 Class II Terminated

Recalled by Advanced Sterilization Products — Irvine, CA

Recall Details

Product Type
Devices
Report Date
June 17, 2015
Initiation Date
May 11, 2015
Termination Date
July 6, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 units

Product Description

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 achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.

Code Information

5040207003 5040207004 5040308003 5042100008 5042100016 5042100017 5042100018 5042100019 5042100020 5042100021 5042100022 5042100023 5042100024 5042100025 5042100033 5042100034 5042100035 5042100036 5042100037 5042100038 5042100039 5042100040 5042100060 5042100061 5042100063 5042100064 5042100065 5042100066 5042100067 5042110002 5042110003 5042110004 5042110005 5042110006 5042120002 5042120006 5042130009 5042130011 5042140029 5042140030 5042140031 5042140032 5042140038 5042140039

Other recalls by Advanced Sterilization Products

  • Z-1197-2017 Class II — STERRAD NX Sterilization System, Product Code: 10033, 10033-002 (January 9, 2017)
  • Z-0965-2017 Class II — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 Th (September 27, 2016)
  • Z-2774-2015 Class II — CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocess (August 10, 2015)
  • Z-2459-2015 Class II — CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 (July 27, 2015)
  • Z-2375-2015 Class II — Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer (July 17, 2015)
  • Z-1714-2015 Class II — EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EV (May 11, 2015)
  • Z-1312-2015 Class II — Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 (December 24, 2014)
  • Z-0845-2015 Class II — STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Ster (November 4, 2014)
  • Z-0842-2015 Class II — STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Ste (November 4, 2014)
  • Z-0846-2015 Class II — STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD S (November 4, 2014)