Recall Z-1312-2019 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
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 lu
| Date | May 20, 2019 (initiated Apr 8, 2019) |
| Status | Terminated |
| Reason | The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount stopcock and MoniTorr Panel Mount stopcock. |
| Root cause | Device Design |
| Action | 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 managi |
| Quantity | 42102 units |
| Distribution | Worldwide Distribution - US Nationwide International distribution to Argentina, American Samoa, Australia, Canada, and Guam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072929 | LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 Integra LifeSciences Corporation, Dec 7, 2007 |