Device recall

Z-0623-2010: Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic…

FDA device recall · Class II · Cordis Corporation

Key facts

Recall number (Z-number) Z-0623-2010
Recall event 53953
Product Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.
Product code DQX
Recalling firm Cordis Corporation
Recall class Class II
Status Terminated
Termination date Aug 11, 2010
510(k) numbers K011905
FEI number 1016427

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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