Recall
regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical…
Resource Optimization & Innovation Llc · 22 April 2015
- Status
- Recall terminated
- Why, in the FDA's words
- “The kits contain an equipment glove component which may contain splits or holes compromising the sterility.”
- Recall began
- 22 April 2015
- Company
- Resource Optimization & Innovation Llc
- Device type
- Product code (FSY)
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.