Z-1250-2017Class II

GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide

Name: Z-1250-2017 GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide
Creator: Vascular Solutions, Inc.
Published: 2017-01-12
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2017-01-12 / Terminated / root cause: labeling and UDI

FDA source

Vascular Solutions, Inc. began a recall of GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the... on 2017-01-12. FDA classified it as Class II and gives the reason as "Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1250-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-12
Posted: 2017-02-23
Terminated: 2018-04-18
Recalling firm: Vascular Solutions LLC
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.
Product code: DQO Catheter, Intravascular, Diagnostic
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot Numbers: 581212, 584392, 594115, 597202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1250-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1250-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-23

Product code DQO

K081846Class IIGrebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc. / cleared 2009-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)