Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model…
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…
Read the official notice →- Date
- 2023-12-20
- Country
- United States
- Brand
- Integra LifeSciences
- Product
- CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No.…
- Classification
- Class I
- Units
- US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of CA, BE, CL.Official notice → - 2024-03-06
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Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the…
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Austria, Bahamas,…Official notice → - 2023-12-13
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Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
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Integra LifeSciences Corp. recalls Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of…
Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2023-05-31
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Integra LifeSciences Corp. recalls Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay,…
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GE Hangwei Medical Systems, Co. LTD recalls The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator,…
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