190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Reported: July 17, 2024 Initiated: June 3, 2024 #Z-2341-2024
Product Description
190828: 2008K@HOME HEMODIALYSIS SYSTEM - 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.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 531 units
- Distribution
- Domestic: Nationwide Distribution. International: Canada.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 531 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2341-2024.
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