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Recall Observatory FDA recall evidence

Device product

Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room

Z-0161-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
138 kits
Official record key
device-enforcement:Z-0161-2017

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: 67078 11/16/2015 66903 11/26/2015 64343 12/24/2015 68965 9/10/2016 68647 9/18/2016 68147 9/28/2016 70233 10/30/2016 71064 12/7/2016

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.