medical Class I Updated 2023-12-20

Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 82

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 10381780520665 All lots distributed
View official government recall

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