Recall
Robotic Pack, part number AMS4389
Windstone Medical Packaging, Inc. · 11 Jan 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.”
- Recall began
- 11 Jan 2017
- Company
- Windstone Medical Packaging, Inc.
- 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.