FDA-Device2017-03-08Class II
General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(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
36 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1304-2017Don't want to check this manually?
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