PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 1, 2017 Initiated: January 12, 2017 #Z-1250-2017

Product Description

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.

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.

Details

Recalling Firm
Vascular Solutions, Inc.
Units Affected
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.
Location
Maple Grove, MN

Frequently Asked Questions

What product 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.. Recalled by Vascular Solutions, Inc.. Units affected: 633.
Why was this product recalled?
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1250-2017.