EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reproce
FDA device recall Z-0965-2017 · posted 2017-01-09 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FEB
- Quantity affected
- 107 units
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2016-09-27
- Date posted
- 2017-01-09
- Date terminated
- 2017-04-17
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOTECH ECR (K152189) | Advanced Sterilization Products (Asp) | 2016-07-20 |
| EVOTECH ECR (K140977) | Advanced Sterilization Products | 2014-12-22 |
| EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392) | Advanced Sterilization Products | 2008-11-13 |
| BIOSTAR OIA SHIGATOX (K061889) | Inverness Medical-Biostar, Inc. | 2006-12-12 |
| EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM (K040883) | Advanced Sterilization Products | 2005-03-15 |