FDA-Device2017-03-08Class II
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
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
390 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2017Don't want to check this manually?
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