FDA-Device2017-03-08Class II

Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472

Windstone Medical Packaging, Inc.
Hazard

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.

Sold states
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.
Affected count
286 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1370-2017

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