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.
This recall has been terminated (originally issued January 12, 2017).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- January 12, 2017
- Terminated
- April 18, 2018
- Recall Number
- Z-1250-2017
- Quantity
- 633
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
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.
Lot / Code Info
Lot Numbers: 581212, 584392, 594115, 597202
Root Cause
Error in labeling
Action Taken
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.