FDAFDA · Food and drugs·Recall number Z-0140-2017
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. 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 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: 62789 11/7/2015 61201 11/8/2015 63413 11/9/2015 67096 11/9/2015 64598 1/29/2016 74803 6/26/2016 57510 6/27/2016 67607 8/21/2016 69801 9/15/2016 71002 10/6/2016 68446 10/9/2016 71403 12/24/2016 72095 1/14/2017 78759 11/5/2017 81077 2/13/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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