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Recall Observatory FDA recall evidence

Device product

Set Up Pack, part number PSS3574(A

Z-1366-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
820 kits
Official record key
device-enforcement:Z-1366-2017

Official wording

Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.

Code information: Lot number and expiration date 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/2018 86927, 7/16/2018 87263, 10/10/2018 89647, 11/23/2018 89913, 10/2/2018 94889, 11/28/2018 95156, 11/14/2018 95674, 12/27/2018 96088, 1/25/2019 96849, 3/7/2019 96990, 5/7/2019 97637, 5/27/2019 98073, 5/23/2019 98373, 5/30/2019 99444, 6/24/2019

Distribution pattern: Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.