Windstone Medical Packaging, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0228-2017)

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:

Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. 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-0228-2017

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: 582 kits

Code Information:

Lot numbers/Expiration dates: 62895 3/16/2014 61290 3/30/2014 57472 4/2/2014 59889 8/8/2014 61313 8/27/2014 62201 10/18/2014 63202 12/12/2014 64163 12/17/2014 65489 3/8/2015 68367 4/13/2015 66793 4/30/2015 69272 9/14/2015 70920 9/30/2015 71438 11/4/2015 66044 11/8/2015 64134 11/10/2015 65690 11/17/2015 71985 11/30/2015 65282 12/1/2015 68490 12/21/2015 69186 12/21/2015 71052 12/25/2015 67699 12/27/2015 67960 12/30/2015 72484 5/28/2016 69442 9/21/2016 80467 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