Recall Z-2053-2009 ยท JXG Shunt, Central Nervous System And Components
Integra Neuro Sciences
Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved t
| Date | Sep 8, 2009 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip. |
| Root cause | Process design |
| Action | An "Urgent-Product Recall Notification" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product. Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorizat |
| Quantity | 274 kits |
| Distribution | Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904883 | OPTYX Baxter Healthcare Corp, Jul 24, 1991 |