Recall Z-1015-2015— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-12-16, terminated 2021-01-29. It names 3 FDA 510(k) clearances: K121421, K121341, K994267. Product: ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System. Reason: Unqualified power assemblies shipped to customers..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-16
- Terminated
- 2021-01-29
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
3 on FDA's record- K121421 — FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- K121341 — FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
- K994267 — FRESENIUS 2008K
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
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Reason for recall
Unqualified power assemblies shipped to customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.