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Recall Observatory FDA recall evidence

Device product

Basic Kit, part number CMP1109(A

Z-1266-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
216 kits
Official record key
device-enforcement:Z-1266-2017

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 84274, 5/14/2018 85771, 7/29/2018 86323, 9/5/2018 87540, 9/30/2018 88763, 12/2/2018 89683, 11/16/2018 95028, 1/5/2019 96659, 5/12/2019 97882, 6/4/2019 98262, 6/15/2019 99290, 9/27/2019

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.