Recall Z-0965-2017 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes.
| Date | Jan 9, 2017 (initiated Sep 27, 2016) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak. |
| Root cause | Nonconforming Material/Component |
| Action | ASP has sent out Service Representatives to all impacted customers to inspect the hoses for the EVOTECH Endoscope Cleaner and Reprocessor System and will replace the hose if required. The firm issued a Technical Bulletin dated 8/22/2016. Customers were instructed to complete online training prior to performing the actions described in the bulletin and follow instructions. For orders and questions call 888-783-7723 or email: RA-ASPUS-ServPartOrd@aspus.jnj.com. |
| Quantity | 107 units |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM Advanced Sterilization Products, Mar 15, 2005 |
| K061889 | BIOSTAR OIA SHIGATOX Inverness Medical-Biostar, Inc., Dec 12, 2006 |
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products, Nov 13, 2008 |
| K140977 | EVOTECH ECR Advanced Sterilization Products, Dec 22, 2014 |
| K152189 | EVOTECH ECR Advanced Sterilization Products (Asp), Jul 20, 2016 |