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 LimiTorr External CSF Drainage and Monitoring Systems provides a closed system for the CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr volume limiting external CSF drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette in the volume limiting external CSF drainage system contains a volume limiting valve which stops drainage when the pre-determined volume (20ml-30ml) is reached. Indications: The LimiTorr 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 in patients with infected CSF shunts, and to monitor ICP.
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- April 8, 2019
- Posted
- May 20, 2019
- Terminated
- January 27, 2021
- Recall Number
- Z-1312-2019
- Quantity
- 42102 units
- Firm Location
- Plainsboro, NJ
Reason for Recall
The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock.
Distribution
Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam.
Lot / Code Info
All lots
Root Cause
Device Design
Action Taken
On April 8, 2019, the firm distributed Urgent Medical Device Correction letters to its affected customers. The communication advised customers of the possible breakage of the stopcock. Customers were advised to take the following precautions: When connecting a fluid-filled transducer (FFT) to the Panel Mount/Transducer Mount stopcocks: " Do not apply excessive force while attaching the FFT to the stopcock. " Take care during the priming process to not torque or bend the syringe and FFT. " Ensure luer lock is "finger tight;" do not over-tighten connection at the stopcock junction. When managing an external ventricular or lumbar drain (EVD) with a FFT attached: " Take care when manipulating the stopcock to zero the FFT and to obtain pressure readings, do not apply excessive force to the stopcock junction. " Use caution during patient transportation and during routine ICU care, to avoid direct contact of the FFT with other devices or equipment. " If the FFT must be flushed or replaced, do not apply excessive torque or force to the FFT/ stopcock junction. " If the FFT is connected to the ICU bedside monitor, ensure the interface cable is positioned so that it does not place excess force on the FFT (e.Q. do not allow cable to touch the floor. Customers were asked to determine if they had any affected product on hand, review and understand the precautions, and complete and return a completed acknowledgement form to the firm. Distributors were asked to forward the customer letter to any customers who received the affected product. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM - 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401 ***UPDATE*** On October 22, 2019, the firm sent out an updated notification informing customers that a new stopcock has been designed for the LimiTorr and MoniTorr, and is now available for replacement of th