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Recall Observatory FDA recall evidence

Device product

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2346-2024

June 03, 2024

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 94775
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2346-2024

Official wording

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.

Code information: Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.

Distribution pattern: Domestic: Nationwide Distribution. International: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.