Home / Recalls / Medical Devices
Windstone Medical Packaging, Inc. recalls Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Recalled October 26, 2016 · FDA recall Z-0256-2017 · Windstone Medical Packaging
Hazard
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. · FDA Class II
Units
102 kits
Sold at
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description
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.
Product
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Manufacturer(s)
Windstone Medical Packaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →