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Recall Observatory FDA recall evidence

Device product

Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room

Z-0229-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
249 kits
Official record key
device-enforcement:Z-0229-2017

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: 64906 11/3/2015 66041 11/6/2015 62111 11/12/2015 65892 12/22/2015 66759 7/29/2016 69271 9/19/2016 68960 9/26/2016 67958 9/28/2016 70334 1/29/2017 74063 5/15/2017 75454 7/8/2017 80958 8/8/2017 78464 9/14/2017 77100 10/25/2017 79659 1/17/2018

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.