FDA-Device2017-03-01Class II
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Vascular Solutions, Inc.
Hazard
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Sold states
US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.
Affected count
633
Manufactured in
6464 Sycamore Ct N, N/A, Maple Grove, MN, United States
Products
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2017Don't want to check this manually?
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