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Recall Observatory FDA recall evidence

Device product

Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room

Z-0179-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
666 kits
Official record key
device-enforcement:Z-0179-2017

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: 58460 7/10/2015 60260 7/18/2015 61708 10/14/2015 65115 11/17/2015 61937 11/29/2015 64687 1/12/2016 68445 3/17/2016 66915 7/5/2016 57957 7/21/2016 67620 9/29/2016 70297 10/26/2016 73096 11/12/2016 72508 11/21/2016 73565 12/20/2016 74851 1/23/2017 75802 4/30/2017 79176 5/5/2017 79475 5/26/2017 79793 6/27/2017

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.