FDAOctober 5, 2023device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciencesintegra
UPCs
10381780520665
Recall history
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