Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01… recallZ-0944-2012 · Integra LifeSciences Corp · initiated Oct 20, 2011
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0944-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 20, 2011
- Posted by the FDA
- Feb 3, 2012
- Recalling firm
- Integra LifeSciences Corp
- Quantity
- 221 Units
- Product code
- GWM
- FDA submissions
- K962928
- Distribution
- Worldwide Distribution-- USA (nationwide ) .
Product description
Integra PAC1 Mod 2 Cables used with the Integra MPM, CAM01 Monitors
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K962928 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CAMINO® 110-4HMTNatus Medical Incorporated · Device, Monitoring, Intracranial Pressure4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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