Recall Z-2044-2016 ยท KOC Accessories, Blood Circuit, Hemodialysis
Fresenius Medical Care Renal Therapies Group, LLC
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
| Date | May 24, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 Techni |
| Quantity | 875 units |
| Distribution | Distributed US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121599 | CRIT-LINE CLIP (CLIC) Fresenius Medical Care-North America, Nov 9, 2012 |