FDA Enforcement
Class II
Ongoing
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Recall: Z-2344-2024
·
Reported July 17, 2024
Enforcement
- Recall Number
- Z-2344-2024
- Event ID
- 94775
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2024
- Initiation Date
- June 3, 2024
- Classification Date
- July 11, 2024
- Address
- 920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States
Description
RTL190395: 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.
Code Info
Model Number: RTL190395 (Rental Units); UDI/DI: 00840861100958; Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L,
Distribution
Domestic: Nationwide Distribution. International: Canada.
Quantity
17 Units