Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology P

FDA device recall Z-0201-2015 · posted 2014-11-10 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.

Action taken

Integra LifeSciences sent an "Urgent Voluntary Medical Device Correction" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer. Complete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below. If you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers for the affected monitors you have and record the total quantity. Complete the other information on the form and return the form by email or fax as indicated. Keep a copy of the form for your records. When your form is received, Integra will schedule this service with your facility and provide a temporary loaner monitor to minimize any disruption this action may cause. Should you have any questions, please contact Neuro Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.

Root cause

Device Design

Status

Terminated

Product code

GWM

Quantity affected

43 (LCX02) and 17 (LCX02R)

Distribution

US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX

Date initiated

2014-08-18

Date posted

2014-11-10

Date terminated

2016-05-11

Location

Plainsboro, NJ

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