Device recall

Z-1362-2016: USE (Ebony) PTA.014" rapid exchange (RX) Peripheral Dilatation Catheter…

FDA device recall · Class II · Us Endovascular

Key facts

Recall number (Z-number) Z-1362-2016
Recall event 73171
Product USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO.
Product code LIT
Recalling firm Us Endovascular
Recall class Class II
Status Terminated
Termination date Nov 30, 2017
510(k) numbers K152230
FEI number 3010747597

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)