Vascular Solutions, Inc. recalls GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer k…

Recall date

January 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1250-2017

FDA classification

Class II

Brand / firm

Vascular Solutions, Inc.

Sold / distributed

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.

Why it was recalled

Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.