Z-0548-2024 Class I Ongoing
FDA device recall Z-0548-2024 was initiated by Integra LifeSciences Corp. on October 5, 2023 and is designated Class I. Reason for recall: 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 ex… The recall status is ongoing. Affected quantity: 4941.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- October 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4941
Product Description
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.
Reason for Recall
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.
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.
Code Information
UDI-DI 10381780520665 All lots distributed