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Devices
Device Recall Hysteroscopy Pack
Model / Serial
Lot number and expiration date 100452, 9/8/2019 100934, 10/6/2019 84549, 5/10/2018 86945, 3/9/2019 95425, 5/20/2019 99399, 6/16/2019 99741, 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
Hysteroscopy Pack, part number AMS4797 || Hysteroscopy Pack, part number AMS4797(A || Hysteroscopy Pack, part number AMS4797(B
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
Recall of Device Recall Hysteroscopy 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
Language
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