EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR...
FDA Device Recall #Z-1715-2015 — Class II — May 11, 2015
Recall Summary
| Recall Number | Z-1715-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 11, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Advanced Sterilization Products |
| Location | Irvine, CA |
| Product Type | Devices |
| 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.
Lot / 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 from Advanced Sterilization Products
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1197-2017 | Class II | STERRAD NX Sterilization System, Product Code: ... | Jan 9, 2017 |
| Z-0965-2017 | Class II | EVOTECH Endoscope Cleaner and Reprocessor Syste... | Sep 27, 2016 |
| Z-2774-2015 | Class II | CIDEX OPA Solution, P/N 20390 for use as a high... | Aug 10, 2015 |
| Z-2459-2015 | Class II | CIDEX Activated Dialdehyde Solution, 4 bottles/... | Jul 27, 2015 |
| Z-2375-2015 | Class II | Wall Chart for STERRAD 100NX System, P/N 10104.... | Jul 17, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.