FDAFDA · Food and drugs·Recall number Z-0154-2017
Body Contour Pack, Kit part number PSS1749 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: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 64597 1/6/2016 65800 11/5/2015 70762 10/25/2016 72336 12/9/2016 72759 1/24/2017 73439 1/27/2017 74083 4/25/2017 75079 6/25/2016 77743 9/17/2017 80762 8/2/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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