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Crédits
Devices
Ortho Pack
Modèle / numéro de série
Lot Numbers/ Expiration Dates: 74829 5/25/2017 78510 8/8/2017 79116 11/5/2017 79279 1/18/2018
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Ortho Pack, Kit number PSS3466 and PSS3466(A || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
Rappel de Ortho Pack
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Fabricant
Windstone Medical Packaging, Inc.
Adresse du fabricant
Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
Société-mère du fabricant (2017)
Windstone Medical Packaging Inc.
Source
USFDA
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Device Recall Minor/General/Ortho Pack
Modèle / numéro de série
Lot number and expiration date 100087, 9/21/2019 85714, 7/29/2018 94551, 1/29/2019 95225, 1/30/2019 96081, 6/4/2019
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Minor/General/Ortho Pack, part number PSS3258(B
Manufacturer
Windstone Medical Packaging, Inc.
Device Recall Ortho Pack
Modèle / numéro de série
Lot number and expiration date 88900, 10/10/2018 94563, 1/4/2019 95875, 1/6/2019 96652, 3/8/2019 97170, 5/5/2019 98072, 5/1/2019 98589, 10/12/2019
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
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.
Description du dispositif
Ortho Pack, part number PSS3466(A
Manufacturer
Windstone Medical Packaging, Inc.
Major Ortho Pack
Modèle / numéro de série
Lot Numbers/ Expiration Dates: 59180 8/13/2013 58144 11/7/2013 63191 12/3/2013 62098 12/6/2013 61064 12/13/2013 61592 12/16/2013 63809 12/17/2013 62398 12/19/2013 60127 12/20/2013 59454 1/25/2014 66802 1/31/2014 67030 1/31/2014 59839 2/16/2014 61296 2/21/2014 65291 2/28/2014 68567 9/5/2014 62930 9/20/2014 67877 9/21/2014 64458 9/30/2014 71056 10/11/2015 68946 10/26/2015 69206 5/10/2016 69631 5/23/2016 70482 5/29/2016 71057 6/4/2016 57292 6/11/2016 57780 6/23/2016
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Major Ortho Pack, kit number 002647-12 and 002647-13 || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Minor Ortho Pack
Modèle / numéro de série
Lot Numbers/ Expiration Dates: 59453 8/2/2013 58726 8/21/2013 62658 12/11/2013 63489 12/17/2013 61162 12/21/2013 60183 12/29/2013 65535 1/31/2014 66430 1/31/2014 66807 1/31/2014 61804 2/7/2014 67876 9/5/2014 64144 9/7/2014 64457 9/30/2014 64909 9/30/2014 69781 5/2/2016 68945 5/10/2016 71058 6/4/2016 57425 6/28/2016
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Minor Ortho Pack, Kit number 002646-12 and 002646-13 || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Minor/General/Ortho Pack
Modèle / numéro de série
Lot Numbers/ Expiration Dates: 75820 6/11/2016 75698 6/25/2016 75713 6/25/2016 68016 9/28/2016 70207 9/28/2016 69484 10/9/2016 71296 12/4/2016 72356 3/14/2017 73927 5/24/2017 76051 7/13/2017 74538 6/25/2018
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Description du dispositif
Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
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