Skip to content
Recall Observatory FDA recall evidence

Device product

Ortho Minor Pack, part number AMS3710(A

Z-1354-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
664 kits
Official record key
device-enforcement:Z-1354-2017

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 100234, 9/8/2019 84944, 6/4/2018 85366, 7/23/2018 85662, 9/29/2018 86669, 9/15/2018 87127, 11/21/2018 89042, 12/12/2018 89735, 11/12/2018 95813, 1/28/2019 96010, 1/26/2019 97466, 5/28/2019 98514, 6/30/2019 99386, 6/10/2019

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.