Recall Z-1250-2017 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
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.
| Date | Jan 12, 2017 |
| Status | Terminated |
| Reason | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. |
| Root cause | Error in labeling |
| Action | Consignees were sent on 1/12/2017 a Vascular Solutions "Urgent Medical Device Recall" letter dated January 11th, 2017. The letter identified the problem and product involved in the recall. The letter provided "Your Immediate Action Is Required". This included to remove the product from inventory and to complete and return the VSI's Account Inventory Form to VSIs Customer Service Dept. |
| Quantity | 633 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081846 | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 Vascular Solutions, Inc., Jan 28, 2009 |