FDAFDA · Food and drugs·Recall number Z-0221-2017
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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: 57846 11/27/2014 58334 11/16/2014 60660 7/21/2015 61766 7/22/2015 62797 10/20/2015 63414 1/30/2016 66908 11/26/2015 67932 4/9/2016 68546 6/11/2016 71757 9/7/2016 72106 9/2/2016 72622 8/25/2016 73283 8/5/2016 73423 8/13/2016 73765 8/2/2016 74067 8/16/2016 74310 12/8/2016 75360 2/4/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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