Reported Jun 3, 2020 · Terminated
Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* *…
Clinical Innovations, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clinical Innovations, LLC · 747 W 4170 S · Murray, UT · 84123-1364
Is this the product you have?
- Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL
- INNOVATIONS ManufacturerClinical Innovations, LLC* * *Reorder
- NumberUM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled
- Lot codes and dates
- Model NumberUM750
- Lot Number181183
- Amount recalled
- 280 devices
Why it was recalled
An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result in a delay in surgery and additional surgical interventions to completed the procedure. There was a report of an injury.
This product could cause temporary or reversible health problems — stop using it.
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