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Recall Observatory FDA recall evidence

Device product

Transvaginal Pack, part number CMP1767

Z-1376-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
650 kits
Official record key
device-enforcement:Z-1376-2017

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 85689, 7/24/2018 85859, 8/1/2018 86125, 11/14/2018 89073, 11/25/2018 89074, 11/22/2018 89211, 12/11/2018 89212, 12/3/2018 89273, 6/15/2019 97315, 5/6/2019 97489, 6/27/2019 98343, 6/10/2019 98344, 9/9/2019

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.