Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0124-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2019-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0124-2020
Date of alert
2019-09-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Reported risk: There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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