CLASS II Device recall · Reported 1 Mar 2017 · FDA Enforcement Report

GrebSet Micro-Introducer Kit recalled by Vascular Solutions

Vascular Solutions is recalling GrebSet Micro-Introducer Kit, distributed nationwide in the US. The recall was initiated on 12 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 581212, 584392, 594115, 597202

Quantity recalled633

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1250-2017
FDA event ID: 76363
Recalling firm: Vascular Solutions, Maple Grove, MN
Classification: Class II
Status: Terminated
Recall initiated: 12 Jan 2017
FDA classified: 23 Feb 2017
Reported: 1 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

12 Jan 2017	Recall initiated by company
23 Feb 2017	Classified by FDA	+42 days
1 Mar 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Delaware Florida Georgia Iowa Idaho Louisiana Maryland Maine Missouri Mississippi New Hampshire New Jersey New York Ohio Oklahoma Oregon

Questions about this recall

Is GrebSet Micro-Introducer Kit recalled?

Yes. Vascular Solutions recalled GrebSet Micro-Introducer Kit on 12 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1250-2017.

Why was it recalled?

Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.

Which lots are affected?

Lot Numbers: 581212, 584392, 594115, 597202

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
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28 Oct 2020Device	CLASS I	Langston Dual Lumen Catheter recalled by Vascular Solutions	Vascular Solutions	Other	Nationwide
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