Device recall

Z-0591-03: Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300…

FDA device recall · Class III · Symbiosis Corp.

Key facts

Recall number (Z-number) Z-0591-03
Recall event 25502
Product Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
Product code DQX
Recalling firm Symbiosis Corp.
Recall class Class III
Status Terminated
Termination date Jul 13, 2012
510(k) numbers K962572
FEI number 1051710

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

Browse all FDA device recalls (products)