Recall record at a glance
| Official record | Z-1714-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Advanced Sterilization Products |
| Report date | Jun 17, 2015 |
| Recall initiation date | May 11, 2015 |
| Quantity | 825 units |
| Location | Irvine, CA, United States |
Official product description
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. 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 achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.
Why the product was recalled
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.
Distribution information
Worldwide Distribution-US (nationwide) and the countries of Australia, Singapore, Canada, and Thailand.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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