Integra LifeSciences Recalls LimiTorr and MoniTorr Stopcock Components
Integra LifeSciences is recalling LimiTorr and MoniTorr stopcock components due to a complaint trend regarding breakage.
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 LimiTorr Volume Limiting External CSF Drainage and Monitoring Systems and MoniTorr Panel Mount stopcock components. The affected products include the LimiTorr INS9020, INS9020SP1, INS9030, and INS9030SP1 models. The recall covers 42,102 units distributed worldwide, including the United States, Argentina, American Samoa, Australia, Canada, and Guam.
The recall was initiated because the firm identified a complaint trend regarding the breakage of the LimiTorr Transducer Mount stopcock and the MoniTorr Panel Mount stopcock. These components are part of a closed system designed to drain and monitor cerebrospinal fluid (CSF) from the brain or lumbar subarachnoid space to reduce intracranial pressure.
Healthcare facilities and consumers who have these devices should stop using the affected stopcock components and contact Integra LifeSciences Corp. for further instructions or replacement. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-9030 LIMITORR VOLUME LIMITING EVD 30 ML LimiTorr INS9030SP1 INS-9030SP1 LIMITORR VOLUME LIMITING EVD 30 ML Product Usage: The…
- 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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