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Recall Observatory FDA recall evidence

Device product

Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room

Z-0211-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0211-2017

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: 63879 1/23/2014 58286 3/18/2014 58810 6/21/2014 62512 10/18/2014 63024 12/13/2014 65774 2/25/2015 68072 4/17/2015 68548 4/25/2015 70982 11/26/2015 73402 3/14/2016 74837 3/22/2016 75198 4/20/2016 67703 7/1/2016 78551 7/30/2016 78600 7/30/2016 68823 9/11/2016 68713 9/20/2016 71080 12/26/2016 72020 1/10/2017 73647 1/28/2017 73205 3/9/2017 73034 3/23/2017 77621 7/21/2017 79992 8/1/2017 77815 8/11/2017 80859 8/31/2017 77783 10/10/2017 75744 10/21/2017 79326 1/13/2018

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.