CereLink ICP Extension Cable Recalled for Out of Range Readings
Integra LifeSciences is recalling CereLink ICP Extension Cables due to a design defect causing out of range readings. The Class I recall affects 4,941 units distributed nationwide and internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall indicates potential for serious adverse health consequences. An intracranial pressure monitor malfunction providing inaccurate readings could directly affect patient diagnosis and treatment decisions.
Plain-English summary
Integra LifeSciences Corp. is expanding a recall to include all CereLink ICP Extension Cables (Model No. 826845). The cables are used with the Codman CereLink Intracranial Pressure Monitor. An original recall of the Cerelink was initiated in June 2022; this expansion adds the extension cables to that recall.
The extension cables may malfunction and produce out of range pressure readings from the intracranial pressure monitor. Inaccurate readings could affect patient diagnosis and treatment decisions. This is classified as a Class I recall by the FDA due to the potential for serious patient impact.
Approximately 4,941 extension cable units have been distributed to facilities throughout the United States and internationally to Australia, New Zealand, Canada, and Europe/Middle East/Africa.
Integra LifeSciences is implementing a corrective design change to the extension cables. Healthcare providers should discontinue use of affected cables and contact the manufacturer for replacement units. All lot numbers of the extension cable are affected (UDI-DI 10381780520665).
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device
- Affected units
- 4,941
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 10381780520665 All lots distributed
Distribution
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