Integra LifeSciences recalls MoniTorr INS1100 CSF Drainage Systems used with Pole Mount System due to reported breakage of transducer mount stopcocks. Affected patients should stop using the device immediately.
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Integra LifeSciences is recalling MoniTorr INS1100 CSF Drainage Systems used with Pole Mount System because complaints show these stopcocks can break. This breakage could lead to complications in patients needing cerebrospinal fluid drainage.
The stopcocks that connect the drainage system to the patient can break, potentially causing leaks or disconnections in the cerebrospinal fluid drainage system. This could lead to complications like infection or improper pressure monitoring in patients with brain or spinal fluid drainage needs.
Patients using the MoniTorr INS1100 CSF Drainage System with Pole Mount System for brain or spinal fluid drainage are affected. Those with medical devices requiring frequent monitoring are at higher risk.
Check for the MoniTorr INS1100 CSF Drainage System with Pole Mount System. The product is used for cerebrospinal fluid drainage and has been sold to patients needing brain or spinal fluid monitoring.
The MoniTorr INS1100 CSF Drainage System with Pole Mount System should be stopped using immediately due to reported breakage risks.
Integra LifeSciences has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Breakage of the stopcocks could lead to leaks or disconnections in the cerebrospinal fluid drainage system, potentially causing complications like infection or improper pressure monitoring.
Check for the MoniTorr INS1100 CSF Drainage System with Pole Mount System used for cerebrospinal fluid drainage in patients needing brain or spinal fluid monitoring.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1311-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1311-2019 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
