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Recall Observatory FDA recall evidence

Device product

ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room

Z-0181-2017

April 22, 2015

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 71968
Status
Terminated
Classification
Class II
Quantity
123 kits
Official record key
device-enforcement:Z-0181-2017

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: 63064 11/3/2015 64818 1/4/2016 71870 12/17/2016 72451 1/7/2017 73240 3/8/2017 72702 3/30/2017 77335 8/10/2017 81025 1/3/2018

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.