Recall Z-2130-2016 ยท NVE Washer, Cleaner, Automated, Endoscope
Custom Ultrasonics, Inc.
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
| Date | Jul 6, 2016 (initiated May 6, 2016) |
| Status | Terminated |
| Reason | To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. |
| Root cause | Process control |
| Action | Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing opti |
| Quantity | 2,345 units |
| Distribution | Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.