Device recall

Z-0124-2020: Cerelink ICP Monitor, Model Number 826820; intended for use as an interface…

FDA device recall · Class II · Integra LifeSciences Corp.

Key facts

Recall number (Z-number) Z-0124-2020
Recall event 83831
Product Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Product code GWM
Recalling firm Integra LifeSciences Corp.
Recall class Class II
Status Open, Classified
510(k) numbers K183406
FEI number 3003418325

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)