Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0166-2017)

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:

Custom Pack - with Introducer Kit, Kit number TVS4011NI(K and TVS4011NI(L 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-0166-2017

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: 1470 kits

Code Information:

Lot Numbers/ Expiration Dates: 62733 11/3/2015 62734 11/11/2015 63822 11/15/2015 63851 1/1/2016 64256 1/3/2016 64255 1/13/2016 63852 4/2/2016 69318 7/14/2016 69233 7/18/2016 69910 9/17/2016 70959 12/6/2016 70958 1/3/2017 73965 1/9/2017 73697 1/20/2017 73698 1/23/2017 75426 5/18/2017 73966 5/20/2017 76637 6/11/2017 76070 6/30/2017 78670 8/13/2017 78276 9/30/2017

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