Recall record at a glance
| Official record | Z-2700-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Steris Corporation |
| Report date | Aug 5, 2020 |
| Recall initiation date | Jun 26, 2020 |
| Quantity | 1283 |
| Location | Mentor, OH, United States |
Official product description
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
Why the product was recalled
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
Distribution information
Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.
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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