Recall Z-1369-2008 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization Products
EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
| Date | Aug 8, 2008 (initiated Feb 13, 2008) |
| Status | Terminated |
| Reason | Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points). |
| Root cause | Other |
| Action | Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs. |
| Quantity | 2 units |
| Distribution | Worldwide Distribution --- including USA and countries of Canada and Japan. |
| FDA record | Open on fda.gov |