The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1250-2017·Announced 2017-03-01

Vascular Solutions Recalls GrebSet Micro-Introducer Kits Due to Shelf Life Discrepancy

Vascular Solutions is recalling 633 units of GrebSet Micro-Introducer Kits because the guidewires have a shorter shelf life than the kit expiration date.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling/shelf-life discrepancy rather than a direct contamination or structural failure, fitting the Moderate criteria for minor labeling errors or low-risk issues.

Plain-English summary

Vascular Solutions, Inc. is recalling 633 units of the GrebSet Micro-Introducer Kit, model 7941. The recall involves four specific lot numbers: 581212, 584392, 594115, and 597202. These kits are intended to facilitate the percutaneous placement of guidewires in the vascular system and for the delivery of contrast media to vascular sites.

The recall was initiated because the guidewires contained in these kits have a shelf life that is shorter than the expiration date listed on the kit. This discrepancy could result in the use of expired guidewires if the kit expiration date is relied upon exclusively.

The affected products were distributed nationwide in the United States, specifically in the states of New Hampshire, Maine, Vermont, New York, Louisiana, Mississippi, Alabama, California, Iowa, Washington, Oregon, Maryland, Delaware, Pennsylvania, New Jersey, Idaho, Texas, Oklahoma, Missouri, Wisconsin, Georgia, Florida, Arkansas, Ohio, and Arizona. Healthcare facilities and users should check their inventory for these specific lot numbers and stop using the affected kits.

The recalled product

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.
Manufacturer
Vascular Solutions, Inc.
Category
Medical Device — Vascular Access
Hazard
Affected units
633

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot Numbers: 581212
  • 584392
  • 594115
  • 597202

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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