FDAFDA · Food and drugs·Recall number Z-0249-2017
Newport Coast Basic Pack, Kit number 007484-1 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 Numbers/ Expiration Dates: 59310 7/9/2015 63339 11/11/2015 61486 11/27/2015 65400 11/30/2015 65399 12/26/2015 67044 4/5/2016 67905 5/13/2016 75637 6/25/2016 74959 8/5/2016 71107 8/11/2016 71635 8/29/2016 74764 1/15/2017 78706 9/26/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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