Recall Z-1250-2017— Vascular Solutions, Inc.

Name: FDA recall Z-1250-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-12

Class II · Terminated

Class II FDA medical device recall by Vascular Solutions, Inc., initiated 2017-01-12, terminated 2018-04-18. It names one FDA 510(k) clearance: K081846. Product: 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: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date..

Recalling firm: Vascular Solutions, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-12
Terminated: 2018-04-18
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K081846 — GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951Vascular Solutions, Inc.·cleared 2009-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.