Skip to content
Recall Observatory FDA recall evidence

Device product

Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital operating room

Z-0249-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
280 kits
Official record key
device-enforcement:Z-0249-2017

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: 59310 7/9/2015 63339 11/11/2015 61486 11/27/2015 65400 11/30/2015 65399 12/26/2015 67044 4/5/2016 67905 5/13/2016 75637 6/25/2016 74959 8/5/2016 71107 8/11/2016 71635 8/29/2016 74764 1/15/2017 78706 9/26/2017

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.