Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1284-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 8, 2017

Recall Number: Z-1284-2017

Event ID: 76280

Reason for Recall:

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Status: Terminated

Product Quantity: 4155 kits

Code Information:

Lot number and expiration date 100084, 10/2/2019 100678, 10/22/2019 100683, 10/13/2019 100700, 9/5/2019 100771, 7/9/2019 100772, 7/23/2019 101188, 9/6/2019 101555, 9/9/2019 84253, 5/12/2018 84254, 5/25/2018 84377, 9/10/2018 84493, 5/28/2018 84494, 5/28/2018 84495, 6/22/2018 84681, 7/22/2018 84682, 7/29/2018 84853, 7/22/2018 84919, 6/3/2018 86006, 8/22/2018 86135, 9/29/2018 86853, 10/31/2018 87162, 8/10/2019 87171, 8/20/2018 87229, 10/5/2018 87582, 12/28/2018 87615, 12/17/2018 88006, 9/23/2018 88227, 9/5/2018 88559, 11/14/2018 88573, 11/12/2018 88574, 11/14/2018 88692, 2/28/2018 88693, 12/9/2018 88899, 11/24/2018 89221, 12/7/2018 89554, 12/9/2018 89555, 1/6/2019 89762, 1/10/2019 94731, 11/12/2018 95058, 1/18/2019 95061, 1/13/2019 95477, 12/7/2018 95510, 1/25/2019 95631, 3/7/2019 95654, 1/10/2019 95874, 6/27/2019 96054, 1/13/2019 96361, 3/10/2019 96458, 1/25/2019 96477, 1/25/2019 96478, 6/23/2019 96834, 6/10/2019 96988,6/9/2019 97000, 6/29/2019 97166, 5/11/2019 97547, 5/7/2019 97820, 6/7/2019 98230, 6/8/2019 98588, 6/7/2019 98753, 6/3/2019 99515, 9/21/2019 99516, 9/30/2019 99564, 9/8/2019 99603, 10/4/2019

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated