FDA-Device2017-03-08Class II
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
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
276 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief