CereLink ICP Extension Cable recall
CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No.…
Why was CereLink ICP Extension Cable recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 10381780520665 All lots distributed
- Product
- CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No.…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 4941
- Distribution
- 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.
- Recall date
- December 20, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)