Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1311-2017)

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:

Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part number PSS1843(A

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 8, 2017

Recall Number: Z-1311-2017

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: 102 6 kits

Code Information:

Lot number and expiration date 100610, 8/6/2018 84646, 5/12/2017 84692, 7/28/2017 84730, 5/18/2017 84851, 6/1/2017 84859, 2/28/2017 85509, 7/1/2017 86309, 8/26/2018 86748, 8/17/2018 86839, 8/2/2018 86937, 10/14/2017 87631, 10/5/2017 87866, 9/15/2018 88208, 4/6/2017 88209, 7/31/2017 88266, 10/29/2018 88267, 1/5/2020 88279, 1/3/2019 88402, 11/2/2017 88875, 10/31/2017 89734, 12/16/2017 94987, 3/21/2018 95112, 2/2/2018 96198, 2/10/2018 96608, 1/7/2018 97288, 2/7/2018 97796, 5/6/2018 98564, 3/19/2018 99383, 5/11/2018

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