Device recall

Z-0802-2015: GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing…

FDA device recall · Class I · Leonhard Lang Gmbh

Key facts

Recall number (Z-number) Z-0802-2015
Recall event 69930
Product GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. . Product Usage: Usage: Skintact Pediatric Multifunction Electrodes are for use on pediatric patients, less than 8 years of age, or weighing less than 25 kg (55 lbs), for external…
Product code MKJ
Recalling firm Leonhard Lang Gmbh
Recall class Class I
Status Terminated
Termination date Aug 13, 2015
510(k) numbers K081371
FEI number 6736

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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