Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1350-2017)

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:

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 8, 2017

Recall Number: Z-1350-2017

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: 1125 kits

Code Information:

Lot number and expiration date 100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018

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