Skip to content
Recall Observatory FDA recall evidence

Device product

Minor Procedure Pack, part number AMS4799

Z-1342-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
365 kits
Official record key
device-enforcement:Z-1342-2017

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 100253, 3/31/2018 88213, 4/30/2017 88671, 4/13/2017 88876, 4/22/2017 89097, 4/30/2017 89205, 4/15/2017 94555, 3/31/2017 94588, 3/31/2017 95305, 3/31/2017 96331, 10/26/2017 97150, 11/30/2017 98711, 11/30/2017

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.