FDAFDA · Food and drugs·Recall number Z-0279-2017
Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room
Published October 26, 2016 · Recall initiated: April 22, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
- Lot
- Lot Number/ Expiration Date: 63911 6/1/2014 61913 8/10/2014 71796 9/3/2014 68840 9/12/2014 58646 12/17/2014 74391 6/18/2016 78100 6/30/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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