Recall
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc. · 22 April 2015
- Status
- Recall terminated
- Why, in the FDA's words
- “The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.”
- Recall began
- 22 April 2015
- 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.