Recall Z-0944-2012 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
| Date | Feb 3, 2012 (initiated Oct 20, 2011) |
| Status | Terminated |
| Reason | Some of the connector cables associated with Integra's intracerebral pressure (ICP) monitors may cause temporary interference with the ICP waveform on the monitor display. |
| Root cause | Under Investigation by firm |
| Action | Integra sent a Urgent Product Recall Notification letter dated October 20, 2011, via FedEx, email, and fax to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to examine their inventory at your earliest convenience. If you have an effected PAC1 cable, please complete the attached Recall Acknowledgement Form and return it to Integra Customer Service per the instructions on the form. An Integra Sales Representative will contact you to assist in the return and replacement of new cables at no cost |
| Quantity | 221 Units |
| Distribution | Worldwide Distribution-- USA (nationwide ) . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) Camino Neurocare, Inc., Dec 20, 1996 |