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Devices
Device Recall Catheter Pack
Model / Serial
Lot number and expiration date 84598 4/16/2017 84599 5/8/2018 85277 5/11/2018 85342 5/17/2018 85456 6/3/2018 85629 6/11/2018 85630 8/21/2018 87145 10/15/2018 89443 8/23/2018 89892 11/30/2018 95180 8/24/2018 95298 11/21/2018 95789 11/11/2018 96424 12/26/2018 96494 12/17/2018 96945 3/11/2019 97753 4/3/2019 97817 4/12/2019 98124 4/18/2019 98703 5/23/2019 98704 6/7/2019 98940 6/30/2019 99561 6/17/2019 99900 6/29/2019
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
Catheter Pack, part number AMS4399(A
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
Recall of Device Recall Catheter 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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