MoniTorrTM
Integra Lifesciences Corporation · Model SP0206 · UDI-DI 10381780072003
Description
MONITORR ICP The MoniTorr ICP External CSF Drainage and Monitoring System provides a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick, and accurate alignment with the patient and secure, positive or negative pressure level setting. The system has also been designed to provide for ease of patient transport through a compact design and an antimicrobial hydrophobic vent feature that resists occlusion. Common features include a calibrated graduated burette, a drainage bag, sampling/aspiration sites, and an increased green stripe pressure tubing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-10 | Integra LifeSciences Corp. (NeuroSciences) | Out-of-specification endotoxin result that did not meet the acceptance criteria. |
| 2024-12-16 | Integra LifeSciences Corp. | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-12-16 | Integra LifeSciences Corp. | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-12-16 | Integra LifeSciences Corp. | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-05-07 | Integra LifeSciences Corp. | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. |
| 2024-05-07 | Integra LifeSciences Corp. | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| 2024-05-07 | Integra LifeSciences Corp. | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| 2023-11-28 | Natus Medical Incorporated | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| 2023-11-28 | Natus Medical Incorporated | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| 2023-06-28 | Medtronic Neurosurgery | Product labeling contains incorrect expiration date |
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