Clinical Innovations Recalls Clearview Total Uterine Manipulator Due to Defective Tip Support
Clinical Innovations is recalling 280 Clearview Total Uterine Manipulators (model UM750) because a missing notch on the tip support may prevent proper attachment of surgical components.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that there was a report of an injury, which meets the rubric criteria for a score of 4 (Severe) due to significant injury reports.
Plain-English summary
Clinical Innovations, LLC is recalling 280 units of the Clearview Total Uterine Manipulator, model UM750, lot 181183. The recall was initiated because an incorrect component was used during manufacturing, resulting in a uterine manipulator tip support that lacks the required notch to attach the spacer and/or colpotomy cup.
The affected devices were distributed internationally to Japan. The defect may result in a delay in surgery and additional surgical interventions to complete the procedure. The source text notes that there was a report of an injury associated with this issue.
Healthcare providers and facilities that have received these devices should stop using them and contact Clinical Innovations, LLC for further instructions on the recall process.
The recalled product
- Product
- Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which…
- Manufacturer
- Clinical Innovations, LLC
- Hazard
- Affected units
- 280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: UM750 Lot Number: 181183
Distribution
Distribution scope not specified by the agency.
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