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Recall Observatory FDA recall evidence

Device product

Upper Torso Tray, part number PSS1554(B

Z-1379-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
222 kits
Official record key
device-enforcement:Z-1379-2017

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 100669, 7/6/2019 83865, 5/24/2018 85348, 7/3/2018 87940, 8/12/2018 88676, 8/12/2018 89622, 9/4/2018 95648, 12/5/2018 96352, 2/8/2019 98061, 4/18/2019 98969, 6/18/2019

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.