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Recall Observatory FDA recall evidence

Device product

CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.

Z-0548-2024

October 05, 2023

Class I

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 93084
Status
Ongoing
Classification
Class I
Quantity
4941
Official record key
device-enforcement:Z-0548-2024

Official wording

Reason: Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

Code information: UDI-DI 10381780520665 All lots distributed

Distribution pattern: US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.