—#106616

Product

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

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K962928
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

Distribution pattern: Worldwide Distribution-- USA (nationwide ) .

Timeline

Recall initiated: 2011-10-20
Posted by FDA: 2012-02-03
Terminated: 2013-06-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.