Recall Z-1618-2014— Fresenius Medical Care Holdings, Inc.
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2014-04-25, terminated 2021-05-18. It names one FDA 510(k) clearance: K121341. Product: Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K. Reason: 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-25
- Terminated
- 2021-05-18
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
Reason for recall
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
Data sourced from openFDA. This site is unofficial and independent of the FDA.