Z-1311-2019 Class I Terminated
FDA device recall Z-1311-2019 was initiated by Integra LifeSciences Corp. on April 8, 2019 and is designated Class I. Reason for recall: The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. The recall status is terminated (terminated January 27, 2021). Affected quantity: 42102 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- January 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42102 units
Product Description
MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide 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 also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.
Reason for Recall
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Distribution Pattern
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
Code Information
All lots