Recall Z-1047-2015 ยท KOC Accessories, Blood Circuit, Hemodialysis
Fresenius Medical Care Holdings, Inc.
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
| Date | Feb 3, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope |
| Root cause | Device Design |
| Action | FMCRTG, LLC representatives contacted Clinics on 12/19/14 by visit/telephone phone) and removed all CLiC units. |
| Quantity | 35 units |
| Distribution | CT, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022536 | \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR Fresenius Medical Care, Oct 30, 2002 |