EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor
FDA device recall Z-1714-2015 · posted 2015-06-05 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.
- Action taken
- A customer notification letter dated 5/7/15 will be sent to all customers on 5/13/15 to inform them that ASP is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels and subsequently pass the cycle without cancellation if there is a disconnected scope. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 888-879-8144. Customers with questions regarding the business reply card are instructed to contact Stericycle at 888-345-4671 and reference event #7781.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FEB
- Quantity affected
- 825 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
- Date initiated
- 2015-05-11
- Date posted
- 2015-06-05
- Date terminated
- 2016-07-06
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOTECH ECR (K140977) | Advanced Sterilization Products | 2014-12-22 |