Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0197-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

General Plastics Pack, Kit number 008617-1 convenience custom kits used for general surgery in hospital operating room

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: October 26, 2016

Recall Number: Z-0197-2017

Event ID: 71968

Reason for Recall:

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Status: Terminated

Product Quantity: 985 kits

Code Information:

Lot Numbers/Expiration Dates: 60558 11/6/2014 58503 11/9/2014 58887 11/15/2014 61480 11/21/2014 61881 5/16/2015 62122 5/25/2015 72125 3/12/2016 56859 5/22/2016 57574 6/26/2016 75367 10/18/2016 78105 10/20/2016 72126 10/21/2016 73669 10/23/2016 74705 10/23/2016 72127 10/27/2016 76745 4/2/2017 75824 4/23/2017 79786 8/6/2017

Distribution Pattern:

Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Voluntary or Mandated:

Voluntary: Firm initiated