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Recall Observatory FDA recall evidence

Device product

Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room

Z-0180-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
304 kits
Official record key
device-enforcement:Z-0180-2017

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: 59053 3/28/2015 77459 9/11/2015 65230 10/26/2015 60259 10/27/2015 61170 11/14/2015 66914 11/26/2015 64387 1/11/2016 63883 1/25/2016 57221 6/19/2016 57956 7/20/2016 77460 7/30/2016 69800 9/6/2016 70560 12/3/2016 72104 1/1/2017 72585 4/19/2017

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.