Integra LifeSciences Recalls MoniTorr CSF Drainage Systems Due to Stopcock Breakage
Integra LifeSciences is recalling MoniTorr CSF Drainage Systems because the LimiTorr Transducer Mount and MoniTorr Panel Mount stopcocks may break.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect (stopcock breakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corp. is recalling specific MoniTorr CSF Drainage Systems. The recall involves 42,102 units of various MoniTorr models, including the 10100, 10102, 10110, 10140, 10150, 10110A, SP0017, SP0042, SP0090, SP0164, and SP0236. The affected products are distributed worldwide, including in the United States, Argentina, American Samoa, Australia, Canada, and Guam.
The firm identified a complaint trend regarding the breakage of the LimiTorr Transducer Mount stopcock and the MoniTorr Panel Mount stopcock. These systems are used to drain cerebrospinal fluid (CSF) from the brain or lumbar subarachnoid space to reduce intracranial pressure and monitor CSF.
Healthcare facilities and consumers should stop using the affected MoniTorr CSF Drainage Systems and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Str
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 42,102
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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