Recall Z-2343-2024— Fresenius Medical Care Holdings, Inc.
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2024-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A. Reason: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-03
- Firm location
- Waltham, MA, United States
Product description
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Reason for recall
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Data sourced from openFDA. This site is unofficial and independent of the FDA.