Z-0944-2012

Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors

Name: Z-0944-2012 Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
Creator: Integra LifeSciences Corp
Published: 2011-10-20
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-20 / Terminated

FDA source

Integra LifeSciences Corp began a recall of Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors on 2011-10-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0944-2012
Status: Terminated
Initiated: 2011-10-20
Posted: 2012-02-03
Terminated: 2013-06-18
Recalling firm: Integra LifeSciences Corporation
Product: Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: 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.
FDA 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. In the meanwhile, you may continue to use the cables until you have been contacted and replacement product has been provided. Distortion of the ICP wave form can be stopped or prevented by keeping the PACI catheter receptacle out of human contact. Please contact Integra Customer Service at 1-800-654-2873.
Quantity in commerce: 221 Units
Distribution: Worldwide Distribution-- USA (nationwide ) .
Product codes and lots: MPM, CAMO1, PAC1 : MEF1100103;MED1102303; MEB1101602; MEF1100203; MEC1100602;MED1101003; MED1102203; MEE1102003; MED1102103; MEC1102302; MEB1101402; MEE1101003; MEF1100703; MEE1101903; MEF1101103; MEB1100803; MEC1103002; MEE1100903; MED1101703; MED1101203; MEC1102902; MEB1101103; MEC1102002; MEB1101502; MED1102203; MEF1100603; MEE1101203; MEC1100102; MEE1101503; MEE1100703; MEF1100403; MED1101303; MED1101403; MEF1100303; MEC1100702; MED1101103; MEC1102402; MEC1101602; MEF1100903; MEE1101303; MED1102003; MEC1103302; MEE1101803; MEE1100803; MEF1100503; MEC1102502; MEC1101702; MEE1101403; MEC1103402; MEF1100803; MEC1102802; MEC1101802;MEF1101003; MEC1103102; MEC1101902; MEC1102102

Product code GWM

K962928Class IICombined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. / cleared 1996-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)