FDA-Device2017-03-08Class II
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
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
606 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2017Don't want to check this manually?
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