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Recall Observatory FDA recall evidence

Device product

Morris Hysto Pack, part number PSS3198(A

Z-1345-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
156 kits
Official record key
device-enforcement:Z-1345-2017

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 101121, 10/5/2019 101680, 10/27/2019 83882, 7/8/2018 87088, 8/16/2018 87496, 9/24/2018 88351, 11/11/2018 89549, 12/22/2018 94996, 1/30/2019 97899, 6/15/2019 98769, 6/25/2019

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.