Skip to content
Recall Observatory FDA recall evidence

Device product

Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room

Z-0231-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
852 kits
Official record key
device-enforcement:Z-0231-2017

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 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 60645 1/13/2014 59179 1/14/2014 67196 1/31/2014 65990 2/28/2014 63190 9/15/2014 62540 9/20/2014 67875 9/28/2014 65484 9/30/2014 69395 5/2/2016 56674 5/29/2016 71054 6/3/2016 57460 6/14/2016 68944 6/20/2016 70475 8/10/2016

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.