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Recall Observatory FDA recall evidence

Device product

Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room

Z-0148-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
256 kits
Official record key
device-enforcement:Z-0148-2017

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 60480 9/6/2015 61269 9/2/2015 63468 11/10/2015 65272 11/13/2015 68625 9/14/2016 69999 10/2/2016 70654 10/11/2016 71789 12/10/2016 72154 3/8/2017 73836 5/16/2017 75272 7/18/2017 76643 7/1/2017 77304 10/8/2017 78543 8/30/2017

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.