Devices

Basic Pack

Model / Serial
Lot Numbers/Expiration Dates: 56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 58068 7/11/2016 58357 7/31/2016 58588 4/10/2015 59298 3/11/2015 59847 9/13/2015 60274 11/4/2015 60353 7/18/2015 60354 7/22/2015 60649 10/28/2015 60797 11/5/2015 61071 10/3/2015 61873 11/28/2015 62203 11/7/2015 62456 11/28/2015 62945 11/2/2015 63065 9/3/2015 63204 11/11/2015 63665 1/29/2016 64166 1/6/2016 64470 1/13/2016 64559 1/29/2016 64750 1/18/2016 64819 10/11/2015 64976 1/14/2016 65020 6/27/2017 65048 11/1/2015 65116 1/17/2016 65411 11/1/2015 65442 11/15/2015 65737 2/15/2016 65804 2/25/2015 65879 12/22/2015 66321 11/12/2015 66395 6/27/2015 66696 11/4/2015 67207 11/16/2015 67521 8/21/2015 67551 7/23/2016 67694 5/2/2015 67700 7/26/2016 67701 7/4/2016 67810 8/10/2016 67966 7/15/2016 68145 8/28/2016 68387 7/6/2016 68410 9/21/2016 68413 9/25/2015 68710 9/13/2016 68711 9/22/2016 68721 9/18/2016 68822 9/5/2016 68857 2/21/2015 69056 11/26/2017 69067 9/20/2016 69191 9/16/2016 69343 9/5/2016 69344 9/11/2016 69345 9/14/2016 69549 9/20/2016 69646 12/24/2016 69893 3/29/2017 70157 9/12/2016 70176 12/12/2015 70966 7/11/2016 70970 10/10/2016 71156 12/27/2016 71450 2/13/2015 71634 1/5/2017 71634 1/5/2017 71788 10/20/2016 71945 1/3/2017 71955 2/7/2015 71987 1/21/2017 72112 3/24/2017 72306 1/7/2017 72490 3/21/2017 72616 3/23/2017 72640 3/12/2017 72978 3/1/2017 72978 3/1/2017 73191 8/21/2016 73203 3/8/2017 73204 4/20/2017 73428 4/4/2017 73645 1/22/2017 73646 4/5/2017 73826 7/27/2017 73933 4/13/2017 73933 4/13/2017 73934 5/3/2017 74061 1/16/2017 74442 4/20/2017 74460 5/9/2017 75094 5/4/2017 75255 6/21/2017 75455 6/25/2016 75646 7/16/2017 75745 6/27/2016 75830 7/9/2017 75902 7/11/2017 76026 7/2/2017 76034 7/23/2017 76083 4/23/2017 76141 7/9/2017 76142 4/23/2017 76152 7/30/2016 76161 8/30/2017 76236 7/15/2016 76662 10/25/2017 76680 8/29/2017 76917 8/5/2017 76948 8/30/2017 77315 10/1/2017 77434 8/14/2017 77518 9/27/2017 77771 10/9/2017 77845 8/23/2017 78027 9/2/2017 78325 8/26/2017 78337 11/9/2017 78641 9/2/2017 78743 9/19/2017 78879 11/2/2017 78980 1/6/2018 79248 9/10/2017 79315 1/17/2018 79497 1/2/2018 79657 2/2/2018 80442 2/26/2018 80608 1/19/2018 80916 1/9/2018
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
Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. || convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
1 Event
- Recall of Basic 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

10 devices with a similar name

Learn more about the data here

Device Recall BASIC PACK W/OUT GOWN

Model / Serial
Code:900345 Lots: 140814984 exp. 11/30/15 140915133 exp. 11/30/15 150116998 exp. 2/28/16 150116805 exp. 2/28/16 150418393 exp. 4/30/16 150518794 exp. 5/31/16
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Only in Puerto Rico.
Product Description
BASIC PACK W/OUT GOWN 11/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Manufacturer
Customed, Inc

Device Recall LAPAROTOMY BASIC PACK

Model / Serial
Code:900547 Lots: 141015717 exp. 10/31/19 150116505 exp. 12/31/15 141216349 exp. 12/31/15 150117000 exp. 2/28/16 150518828 exp. 5/31/16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed Only in Puerto Rico.
Product Description
LAPAROTOMY BASIC PACK 10/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Manufacturer
Customed, Inc

Device Recall Newport Coast Basic Pack

Model / Serial
Lot number and expiration date 101006, 9/30/2019 88154, 11/11/2018 88970, 1/5/2019 96163, 1/23/2019 96254, 5/23/2019 97206, 6/29/2019 99295, 6/24/2019
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
Newport Coast Basic Pack, part number 007484-1
Manufacturer
Windstone Medical Packaging, Inc.

Device Recall Ortho Basic Pack

Model / Serial
Lot number: 101180
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
Ortho Basic Pack, part number AMS6459 || Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer
Windstone Medical Packaging, Inc.

Basic Pack contains Devon Light Glove

Model / Serial
Pack 693-203, 888-2375, 888-2396, 888-2430, 888-2495, 888-2594
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
Product Description
Basic Pack - contains Devon Light Glove || Used during surgery
Manufacturer
Stradis Healthcare, LLC.

5 more

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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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