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Recall Observatory FDA recall evidence

Device product

Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

Z-0276-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
58 kits
Official record key
device-enforcement:Z-0276-2017

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 Number/ Expiration Date: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 62544 1/16/2015 63813 2/28/2015 66309 4/13/2015 67352 11/1/2015 73747 3/1/2016 77176 6/17/2016 56393 7/3/2016 79087 8/31/2016

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.