FDA-Device2017-03-08Class II
Hystero Pack, part number PSS3535(A
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
32 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Hystero Pack, part number PSS3535(A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2017Don't want to check this manually?
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