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Recall Observatory FDA recall evidence

Device product

Eye Plastic Tray, part number PSS1931(A

Z-1298-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
310 kits
Official record key
device-enforcement:Z-1298-2017

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 84566, 3/8/2017 85861, 7/5/2017 86513, 8/27/2017 88308, 11/30/2017 88550, 11/12/2017 88986, 11/1/2017 96822, 2/17/2018 97615, 2/5/2018 97993, 7/9/2018

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.