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Recall Observatory FDA recall evidence

Device product

Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room

Z-0259-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
430 kits
Official record key
device-enforcement:Z-0259-2017

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: 58336 3/5/2014 61990 8/20/2014 61732 9/10/2014 63878 2/9/2015 65773 2/25/2015 64610 3/27/2015 68071 8/5/2015 69931 10/26/2015 71918 2/15/2016 73291 2/22/2016 74558 6/14/2016 77064 7/14/2016 78767 9/5/2016 78000 9/8/2016

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.