FDA Device recall Z-1715-2015
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002 by Advanced Sterilization Products, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1715-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
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 achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
Reason
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.
Identifiers
| code_info | 5040207003 5040207004 5040308003 5042100008 5042100016 5042100017 5042100018 5042100019 5042100020 5042100021…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1715-2015%22
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