Device recall

Z-1849-2020: R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496…

FDA device recall · Class II · Epimed International

Key facts

Recall number (Z-number) Z-1849-2020
Recall event 85339
Product R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Product code GXI
Recalling firm Epimed International
Recall class Class II
Status Terminated
Termination date Jan 28, 2021
510(k) numbers K041021
FEI number 1643059

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

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