Devices

SetUp Pack

Model / Serial
Lot Number/ Expiration Date: 67723 11/19/2015 61928 11/20/2015 56692 7/19/2016 67757 7/22/2016 58305 8/6/2016 58345 8/14/2016 69798 9/14/2016 69922 9/16/2016 69923 9/29/2016 58346 10/4/2016 70578 10/11/2016 68747 10/12/2016 69280 10/23/2016 70579 12/5/2016 70580 12/26/2016 70988 3/23/2017 73558 4/24/2017 74320 5/24/2017 74472 5/25/2017 75989 7/16/2017 77190 7/21/2017 76466 7/22/2017 74850 7/23/2017 76890 7/23/2017 75368 7/30/2017 76891 8/4/2017 76903 8/10/2017 77517 8/29/2017 77987 9/5/2017 77361 10/10/2017 78110 1/9/2018 78111 2/6/2018
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
Set-Up Pack, Kit number PSS1305(B and PSS1305(C || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
- Recall of SetUp Pack

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

4 devices with a similar name

Learn more about the data here

Device Recall Basic Setup Pack

Model / Serial
Lot number and expiration date 101418, 10/9/2019 84727, 5/25/2018 85308, 6/3/2018 85485, 8/5/2018 86644, 9/11/2018 87420, 9/14/2018 88160, 11/15/2018 89015, 10/8/2018 89570, 12/1/2018 94914, 1/21/2019 94920, 1/12/2019 95736, 1/2/2019 96290, 1/28/2019 96902, 8/16/2020 99041, 9/25/2019
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
Basic Setup Pack, part number AMS1787(A || Basic Setup Pack, part number AMS6519
Manufacturer
Windstone Medical Packaging, Inc.

Device Recall SetUp Pack

Model / Serial
Lot number and expiration date 100280, 9/22/2019 101104, 9/14/2019 84089, 6/29/2018 85293, 7/29/2018 85807, 8/21/2018 86209, 9/23/2018 86427, 8/9/2018 86627, 8/11/2019 87734, 9/29/2018 87934, 9/7/2018 87935, 11/21/2018 87936, 12/25/2018 87937, 12/29/2018 89476, 1/28/2019 95646, 1/10/2019 96062, 1/16/2019 96463, 3/8/2019 96464, 6/22/2019 96465, 5/28/2019 96466, 5/29/2019 96807, 6/6/2019 97610, 6/19/2019 97611, 6/17/2019 97878, 9/25/2019 97878, 9/25/2019 99195, 9/14/2019
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
Set-Up Pack, part number PSS1305(C
Manufacturer
Windstone Medical Packaging, Inc.

Device Recall Setup Pack

Model / Serial
Lot numbers: 84197 85135 86063 87112 88181 89030 94937 95806 96599 97277 97705 99303 100020
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
Product Description
Setup Pack, part number AMS3112(A || Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer
Windstone Medical Packaging, Inc.

Basic Setup Pack

Model / Serial
Lot Numbers Expiration Dates 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 69999 10/2/2016 70654 10/11/2016 71789 12/10/2016 72154 3/8/2017 73836 5/16/2017 75272 7/18/2017 76643 7/1/2017 77304 10/8/2017 78543 8/30/2017
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
Basic Setup Pack, kit part number AMS1787(A || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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