Device recall

Z-1250-2017: GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide…

FDA device recall · Class II · Vascular Solutions, Inc.

Key facts

Recall number (Z-number) Z-1250-2017
Recall event 76363
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
Recalling firm Vascular Solutions, Inc.
Recall class Class II
Status Terminated
Termination date Apr 18, 2018
510(k) numbers K081846
FEI number 3002827704

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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