Device recall

Z-1185-2013: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product…

FDA device recall · Class II · Covidien LLC

Key facts

Recall number (Z-number) Z-1185-2013
Recall event 64868
Product Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Product code DRO
Recalling firm Covidien LLC
Recall class Class II
Status Terminated
Termination date Nov 19, 2015
510(k) numbers K012218
FEI number 1282497

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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