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Recall Observatory FDA recall evidence

Device product

Bayview Breast Pack, part number 009080-2

Z-1274-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
126 kits
Official record key
device-enforcement:Z-1274-2017

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 84687, 2/24/2018 86231, 2/9/2018 89386, 4/8/2018 94891, 4/23/2018 95261, 4/12/2018 95968, 4/1/2018 96742, 4/23/2018

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.