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Recall Observatory FDA recall evidence

Device product

Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A

Z-1361-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1361-2017

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 101684, 8/21/2018 84576, 5/19/2017 87746, 10/15/2017 88702, 11/13/2017 89228, 10/1/2017 95000, 1/16/2018 96841, 1/8/2018 97168, 6/11/2018 97250, 7/15/2018 99100, 6/9/2018

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.