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Devices
Percutaneous Entry Kit
Model / Serial
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
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Product Description
Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
Recall of Percutaneous Entry Kit
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Manufacturer
Windstone Medical Packaging, Inc.
Manufacturer Address
Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
Manufacturer Parent Company (2017)
Windstone Medical Packaging Inc.
Source
USFDA
One device with a similar name
Learn more about the data
here
Device Recall Percutaneous Entry Kit
Model / Serial
Lot number and expiration date 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Product Description
Percutaneous Entry Kit, part number TVS4022(D || Percutaneous Entry Kit , part number TVS4022(E || Percutaneous Entry Kit, part number TVS4022(F
Manufacturer
Windstone Medical Packaging, Inc.
Language
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