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Recall Observatory FDA recall evidence

Device product

Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room

Z-0167-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
56 kits
Official record key
device-enforcement:Z-0167-2017

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: 59060 11/3/2015 57225 5/21/2016 57696 7/9/2016 72681 1/11/2017 77152 7/13/2017

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.