Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0164-2017)

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 Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(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-0164-2017

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: 546 kits

Code Information:

Lot numbers/Expiration dates: 62743 8/18/2013 57375 9/5/2013 58352 9/13/2013 58985 1/28/2014 62106 7/14/2014 61743 7/21/2014 63397 12/21/2014 63273 12/26/2014 64371 3/13/2015 64329 3/21/2015 66935 4/22/2015 67471 5/11/2015 68296 9/19/2015 68614 9/27/2015 68614 9/27/2015 70876 10/12/2015 69816 10/14/2015 70681 10/20/2015 71211 10/21/2015 71695 10/26/2015 73064 12/20/2015 72359 12/24/2015 77377 1/19/2016 76155 1/25/2016 81170 7/8/2016

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