Recall Z-2700-2020 ยท FLG Cleaner, Ultrasonic, Medical Instrument
Steris Corporation
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
| Date | Jun 26, 2020 |
| Status | Terminated |
| Reason | A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria. |
| Root cause | Process control |
| Action | On 6/26/2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that a Steris service technician will contact customer facilities within 45 days to inspect their units and reperform the installation/start-up checklist. Users can continue to use their irrigator(s) prior to this inspection. Users were instructed to continue to visually inspect all instruments for visible debris prior to final high-level disinfection or sterilization, and reprocess if needed. In addition, users should continue to clean and maintain the unit before each |
| Quantity | 1283 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.