Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX

Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.

Fresenius Medical Care Renal Therapies Group, LLC issued Recall Letter issued 5/24/16 via certified mail. Clinics actively using the CLiC option have been verbally communicated to stop using the CLiC option at . The other clinics that did not activate the CLiC option have been verbally communicated to not activate the CLiC option at this time. A Software update to all 2008T Hemodialysis machines will be required. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. For technical Inquiries, please contact Technical Services at 1-800-227-2572. Additional medical concerns or questions, please contact the Medical Information and Communication line at 855-616-2309 or website www.fresenius-medinfo.com.