Device recall

Z-2105-2010: Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT…

FDA device recall · Class II · Merit Medical Systems, Inc.

Key facts

Recall number (Z-number) Z-2105-2010
Recall event 56161
Product Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of devices during diagnostic and interventional procedures.
Product code DQX
Recalling firm Merit Medical Systems, Inc.
Recall class Class II
Status Terminated
Termination date Oct 19, 2010
510(k) numbers K092303
FEI number 1721504

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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