EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexi
FDA device recall Z-1123-2013 · posted 2013-04-15 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- 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.
- Action taken
- 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 their EVOTECH ECR system by contacting ASP Professional Services directly at (888) 783-7723 and select option #2.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FEB
- Quantity affected
- 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, S
- Date initiated
- 2013-03-22
- Date posted
- 2013-04-15
- Date terminated
- 2013-11-18
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR (K082392) | Advanced Sterilization Products | 2008-11-13 |