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Recall Observatory FDA recall evidence

Device product

Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room

Z-0228-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
582 kits
Official record key
device-enforcement:Z-0228-2017

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: 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.

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.