Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1356-2017)

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:

Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 8, 2017

Recall Number: Z-1356-2017

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: 561 kits

Code Information:

Lot number and expiration date 80492, 5/3/2018 82502, 6/8/2018 85302, 7/12/2018 88153, 11/13/2018 89116, 12/10/2018 89318, 11/22/2018 95070, 1/29/2019 95088, 11/14/2018 95580, 1/4/2019 95581, 1/4/2019 95582, 1/11/2019 95583, 1/24/2019 97115, 6/12/2019

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