Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0194-2017)

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 Pack I, Kit number CMP1811(B 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-0194-2017

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: 1596 kits

Code Information:

Lot Numbers/Expiration Dates: 59313 4/12/2015 59483 7/22/2015 59876 9/13/2015 61092 9/13/2015 60552 10/29/2015 65936 11/2/2015 61362 11/7/2015 62976 11/8/2015 65432 11/8/2015 66398 11/10/2015 61093 11/15/2015 62301 11/18/2015 62676 12/14/2015 64312 1/6/2016 64793 1/12/2016 64183 1/14/2016 63524 1/17/2016 57212 6/16/2016 57213 7/5/2016 67910 7/15/2016 67594 7/27/2016 58074 8/7/2016 58649 8/30/2016 70167 9/15/2016 67911 9/18/2016 68879 10/9/2016 69319 10/31/2016

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