FDA-Device2017-03-08Class II
Basic Pack (1185), part number AMS6560
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
50 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Basic Pack (1185), part number AMS6560
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2017Don't want to check this manually?
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