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Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP
Recalled December 20, 2023 · FDA recall Z-0548-2024 · Integra LifeSciences
Hazard
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. · FDA Class I
Units
4941
Sold at
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.
Description
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.
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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →