Recall
Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Highland
Resource Optimization & Innovation Llc · 9 Jan 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.”
- Recall began
- 9 Jan 2017
- Company
- Resource Optimization & Innovation Llc
- Device type
- Product code (LRO)
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.