Recall Z-1310-2019 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
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 Strip MoniTorr 10150 10-150 CSF Drainage System Simple Bag and Line MoniTorr 10110A 10-110A CSF Drainage System w/o Manifold S
| 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
| K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Integra Neurosciences, Aug 23, 2002 |
| K062599 | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS Integra LifeSciences Corporation, Sep 27, 2006 |
| K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY Clinical Neuro Systems, LLC, Mar 16, 1992 |