Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0258-2017)

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:

Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D 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-0258-2017

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: 1160 kits

Code Information:

Lot Numbers/ Expiration Dates: 56901 1/31/2015 57410 5/13/2015 57819 5/25/2015 58770 7/19/2015 59874 8/14/2015 60612 10/10/2015 61900 11/6/2015 62135 11/13/2015 64254 11/16/2015 65934 11/18/2015 63855 1/2/2016 64311 1/5/2016 68002 7/12/2016 73542 1/3/2017 74101 1/9/2017 77040 3/11/2017 75746 3/15/2017 78275 3/23/2017 78671 9/10/2017 80514 11/27/2017

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