FDA Device recall Z-0548-2024
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 8…
- FDA Device
- Class I
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class I recall of CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 8… by Integra Lifesciences, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0548-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-05 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
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.
Identifiers
| code_info | UDI-DI 10381780520665 All lots distributed |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2024%22
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