Recall record at a glance
| Official record | Z-1595-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Steris Corporation |
| Report date | May 24, 2023 |
| Recall initiation date | Apr 10, 2023 |
| Quantity | 322 units |
| Location | Mentor, OH, United States |
Official product description
Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
Why the product was recalled
In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
Distribution information
Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: China, Lithuania, Saudi Arabia, Korea, Republic of, Canada, Taiwan, United Kingdom, Spain, Australia, New Zealand, Spain, Brazil, Bahrain, Switzerland, Great Britain, South Africa, Hong Kong, Qatar.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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