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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock."
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…
- 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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