ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure
Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to detect disconnected endoscopes, which poses a risk of inadequate disinfection and potential patient harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because the device may not detect an improper endoscope connection on two channels. If a scope is disconnected, the system may pass the cycle without cancellation, potentially failing to achieve the intended cleaning and high-level disinfection.
The recall involves 44 units of the EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. These devices are indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to clean and disinfect heat-sensitive semi-critical endoscopes.
The affected units were distributed nationwide in the United States and in Australia, Singapore, Canada, and Thailand. Users should contact Advanced Sterilization Products for instructions on how to address the defect.
The recalled product
- Product
- EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to…
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 44
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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