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Recall Observatory FDA recall evidence

Device product

Lower Extremity Pack, part number AMS4669

Z-1335-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
198 kits
Official record key
device-enforcement:Z-1335-2017

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 AMS4669, 85376 AMS4669, 86279 AMS4669, 87657 AMS4669, 88434 AMS4669, 95690 AMS4669, 96189 AMS4669, 96190 AMS4669, 99735 AMS4669, 100446

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.