Windstone Medical Packaging, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1285-2017)

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 - with Introducer Kit, part number TVS4011NI(L

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 8, 2017

Recall Number: Z-1285-2017

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: 840 kits

Code Information:

Lot number and expiration date 85014, 4/30/2018 85448, 7/14/2018 85937, 8/23/2018 87713, 8/9/2018 88092, 11/18/2018 89342, 10/17/2018 89974, 12/5/2018 95212, 12/3/2018 95725, 12/19/2018 96882, 12/9/2018 97051, 5/27/2019 98088, 5/2/2019 98423, 5/25/2019 98852, 5/14/2019

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