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Recall Observatory FDA recall evidence

Device product

Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room

Z-0174-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
648 kits
Official record key
device-enforcement:Z-0174-2017

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: 65805 2/24/2015 59138 8/31/2015 61015 9/17/2015 65118 10/20/2015 65413 11/3/2015 66234 11/8/2015 66921 11/29/2015 57959 8/15/2016 69802 9/27/2016 68607 10/5/2016 71901 10/19/2016 71111 12/26/2016 72510 3/14/2017 76252 4/14/2017 76892 4/23/2017 74517 5/15/2017 73799 5/24/2017 75239 7/15/2017 77363 8/25/2017

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.