Recall Z-1123-2013 ยท FEB Accessories, Cleaning, For Endoscope
Advanced Sterilization Products
EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
| Date | Apr 15, 2013 (initiated Mar 22, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Field Correction letter, dated 3/22/13, was sent to customers who purchased the EVOTECH Endoscope Cleaner and Reprocessor (ECR) HIPOT Testing. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed on what to do if electrical shock occurs. Customers are instructed that they will be contacted in the next 2 weeks on behalf of ASP to schedule HIPOT testing. Customers with questions are instructed to contact Stericycle at (888) 965-5816. Customers are instructed to report complaints or suspected problems with t |
| Quantity | 273 units |
| Distribution | Nationwide Distribution-USA including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR Advanced Sterilization Products, Nov 13, 2008 |