Recall Z-1715-2015 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization Products
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.
| Date | Jun 5, 2015 (initiated May 11, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | A customer notification letter dated 5/7/15 will be sent to all customers on 5/13/15 to inform them that 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 letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 888-879-8144. Customers with questions reg |
| Quantity | 44 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140977 | EVOTECH ECR Advanced Sterilization Products, Dec 22, 2014 |