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Devices
Device Recall ENT Pack
Model / Serial
Lot number and expiration date 84530, 5/25/2018 84588, 5/12/2018 85139, 7/14/2018 85655, 8/1/2018 86310, 9/26/2018 86480, 9/3/2018 86749, 9/21/2018 87287, 8/11/2019 88184, 9/4/2018 88318, 11/19/2018 88647, 10/5/2018 89495, 9/30/2019 89589, 12/10/2018 95103, 1/2/2019 96194, 1/18/2019 96922, 5/11/2019 97787, 6/9/2019 98676, 6/27/2019
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
ENT Pack, part number AMS3237(A || ENT Pack, part number AMS4214
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
Recall of Device Recall ENT Pack
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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
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Device Recall ENT Pack
Model / Serial
Lot numbers: 72702 and 78567
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
ENT Pack, part number AMS2727 || Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer
Windstone Medical Packaging, Inc.
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