FDAFDA · Food and drugs·Recall number Z-1250-2017
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.
Published March 1, 2017 · Recall initiated: January 12, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vascular Solutions, Inc.
- Distributor
- 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.
- Lot
- Lot Numbers: 581212, 584392, 594115, 597202
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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