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Recall Observatory FDA recall evidence

Device product

Hernia Pack, part number AMS3859

Z-1315-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
228 kits
Official record key
device-enforcement:Z-1315-2017

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 101167, 5/30/2019 87349, 6/20/2018 88830, 9/11/2018 89510, 11/29/2018 94616, 11/15/2018 94704, 11/24/2018 95209,11/25/2018 95934, 1/15/2019 97409, 3/6/2019 99486, 3/12/2019

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.