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Recall Observatory FDA recall evidence

Device product

Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E

Z-1292-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
944 kits
Official record key
device-enforcement:Z-1292-2017

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 100007, 2/26/2019 100008, 2/3/2019 100009, 2/10/2019 100322, 4/2/2019 101129, 2/21/2019 84854, 12/26/2017 85111, 12/1/2017 86047, 12/19/2017 86791, 5/7/2018 88616, 5/13/2018 88617, 6/11/2018 88845, 6/12/2018 89076, 10/22/2018 89175, 10/7/2018 89568, 11/9/2018 89715, 11/25/2018 94567, 10/23/2018 97120, 12/7/2018 97562, 11/27/2018 97771, 11/27/2018 98014, 11/11/2018 98014, 11/11/2018 98160, 2/22/2018 98161, 11/21/2018 98162, 11/30/2018 98494, 2/13/2019

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.