Skip to content
Recall Observatory FDA recall evidence

Device product

Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room

Z-0205-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
3444 kits
Official record key
device-enforcement:Z-0205-2017

Official wording

Reason: 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.

Code information: Lot numbers/Expiration dates: 62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017

Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.