FDAFDA · Food and drugs·Recall number Z-0258-2017
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D 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: 56901 1/31/2015 57410 5/13/2015 57819 5/25/2015 58770 7/19/2015 59874 8/14/2015 60612 10/10/2015 61900 11/6/2015 62135 11/13/2015 64254 11/16/2015 65934 11/18/2015 63855 1/2/2016 64311 1/5/2016 68002 7/12/2016 73542 1/3/2017 74101 1/9/2017 77040 3/11/2017 75746 3/15/2017 78275 3/23/2017 78671 9/10/2017 80514 11/27/2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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