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Recall Observatory FDA recall evidence

Device product

Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room

Z-0243-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
600 kits
Official record key
device-enforcement:Z-0243-2017

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: 64509 1/4/2016 63184 1/24/2016 68824 9/2/2016 69550 9/5/2016 71960 1/2/2017 72952 3/12/2017 73688 4/5/2017 73599 4/20/2017 74550 5/7/2017 74782 5/22/2017 75650 7/29/2017 80441 8/9/2017 78329 9/23/2017 76679 10/4/2017 78742 1/4/2018

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.