Recall Z-1549-2015— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2015-02-20, terminated 2021-05-18. It names 2 FDA 510(k) clearances: K121421, K070049. Product: 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.. Reason: The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-20
- Terminated
- 2021-05-18
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Reason for recall
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Data sourced from openFDA. This site is unofficial and independent of the FDA.