Recall Z-0548-2024— Integra LifeSciences Corp.
Class I · Ongoing
Class I FDA medical device recall by Integra LifeSciences Corp., initiated 2023-10-05. It names 2 FDA 510(k) clearances: K232890, K210993. 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..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-10-05
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- K210993 — CereLink ICP Monitor
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.